Medtronic InterStim — Sacral Neuromodulation
InterStim is a family of sacral neuromodulation systems for bladder and bowel dysfunction. A lead near a sacral nerve connects to an implanted pulse generator; treatment modulates neural control and does not mechanically close an outlet. This is the device hub. For assessment, test placement and operative technique, see Sacral Neuromodulation.[1]
History
Sacral nerve stimulation grew out of NIH-funded research at UCSF in the 1970s, which progressed from direct bladder-wall stimulation to spinal cord stimulation and finally sacral root stimulation.[22] The early procedure was an open operation under general anesthesia. The tined lead, introduced in the early 2000s, made placement percutaneous under local anesthesia in two stages, allowed a longer test period (at least 14 days recommended) and reduced lead migration. One review reported that the test-phase response rate almost doubled to about 80%.[23] The FDA approved InterStim for urinary urge incontinence in patients who had failed or could not tolerate more conservative treatments in 1997.[24][42] Indications later expanded to urgency-frequency and non-obstructive retention,[4] and in 2011 to chronic fecal incontinence.[13] The second-generation InterStim II is smaller than the original generator.[23] In a single French center, median observed generator lifespan was 7.29 years for the original InterStim and 5.9 years for InterStim II.[25]
Current Hardware and MRI Eligibility
| Generator | Power | MRI-relevant lead combination |
|---|---|---|
| InterStim II — 3058 | Recharge-free | 978B1 SureScan can support conditional full-body 1.5 T/3 T scanning |
| InterStim X — 97800 | Recharge-free; extended battery generation | 978B1 SureScan |
| InterStim Micro — 97810 | Rechargeable | 978A1 SureScan |
MRI eligibility depends on the complete system, and neither the generator's name nor whether its battery recharges settles it. Older generators or leads and retained or damaged components require their own labeling review. It is incorrect to call every InterStim II head-only or to pair Micro's full-body eligibility with an older 3889 lead.[2]
Medtronic's US MRI guidelines (April 2025) give the conditions for full-body scanning with these three system pairs; the 2025 UK checklist summarizes the same conditions. The patient brings the patient control device (handset and communicator) and patient ID card, and the patient app puts the system in MRI mode, which turns therapy off and displays the scan eligibility. Without a patient control device an active system cannot be prepared, and the appointment may need to be rescheduled. Neither document includes an impedance check before a full-body scan. Other conditions are:[38][39]
| Item | Condition in the US MRI guidelines |
|---|---|
| Scanner | 1.5 T or 3 T horizontal cylindrical; no restriction on MRI manufacturer. At 1.5 T, use circularly polarized (CP) mode with the RF whole-body transmit coil. |
| Gradients | Maximum slew rate 200 T/m/s per axis; maximum spatial field gradient 20 T/m |
| Scan time | 30 minutes of continuous scanning, then a 5-minute wait if the limit is reached |
| Body temperature | 38 °C or lower; no blankets |
| Position | Prone or supine |
| Micro battery | Charged to at least 30%[38] |
| Scan region at or above C7 | Whole-body transmit coil with any receive coil, or a detachable head transmit/receive coil; Normal or First Level Controlled Operating Mode |
| Scan region below C7 | Whole-body transmit coil with any receive coil: B1+rms 2.0 μT or lower at 3 T (SAR 1.4 W/kg if B1+rms is not reported) or 4.0 μT or lower at 1.5 T (SAR 2.0 W/kg); or a detachable lower-extremity transmit/receive coil in Normal or First Level mode |
Other systems are limited to 1.5 T scans of the head with a detachable head transmit/receive volume coil in Normal Operating Mode, with no scan-time limit, after MRI mode is activated or therapy is turned off. This applies to InterStim X or InterStim II implanted with a non-SureScan lead such as 3093 or 3889, and to the older Model 3023. A 3023 is excluded if its serial number falls in listed ranges, and its magnet switch must first be disabled with the Model 8840 clinician programmer if the patient uses a control magnet. The InterStim Twin (7427T) is not eligible for MRI. A depleted or end-of-service InterStim X, InterStim II or eligible 3023 may have a head-only scan without a patient control device if the managing clinician completes Medtronic's eligibility form.[39]
A retained lead fragment does not count as an abandoned component if its total metallic length is 6 cm or shorter, it is at least 2 cm from other metal, it lies in or near the sacral foramen and it comes from a 3093, 3889, 978A1 or 978B1 lead. If only such a fragment remains after explantation, the full-body conditions above apply. After the scan the patient, outside the scanner room, deactivates MRI mode and returns to the previous settings from the same screen. MRI can reset the generator to power-on-reset settings, which then need reprogramming. The guidelines also state that MRI has not been evaluated with test-phase (therapy evaluation) components: the external neurostimulator is MR Unsafe, and all evaluation components are removed before MRI. With more than one active implant, the most restrictive conditions apply.[39] The checklist cites a 2020 conference abstract reporting abnormal electrical impedance in 132 of 710 patients (18.6%) who underwent device interrogation within the first 10 years after implantation; this is a manufacturer-cited conference figure.[38][40] The checklist is a summary and states that the device manuals and the MRI guidelines govern.[38]
Before scanning, verify model numbers, lead status, MRI mode and all scanner, coil and energy limits in the current instructions. External evaluation equipment is distinct from an eligible fully implanted system.[2] A retrospective Swiss series of 55 patients with an InterStim II (191 MRIs, 92% at 1.5 T, 58% of the 1.5 T scans imaging regions other than the head, device turned off) found possibly related complications in 2 scans (1%), both transient pain or heat at the implant site.[26] A prospective series of 11 patients reported no significant adverse events with lumbosacral MRI.[27]
InterStim X has a manufacturer-projected battery life exceeding a decade, potentially up to 15 years at low-energy settings. Micro requires periodic recharging; its advertised 20-minute weekly schedule and 15-year battery performance depend on specified settings and charger placement.[3]
Mechanism
The mechanism is incompletely understood. A 2025 narrative review proposes that stimulation modulates afferent signaling, possibly through sub-sensory activation of pelvic floor muscles, with transmission via the spinal cord to supraspinal structures. It also proposes effects on sympathetic-parasympathetic balance and on neural plasticity at peripheral, spinal and supraspinal levels. These are hypotheses.[28]
Indications and Test Response
Current US labeling covers urinary retention and OAB symptoms after conservative-treatment failure or intolerance, and chronic fecal incontinence after failure of or unsuitability for conservative treatment. Urinary mechanical obstruction must be excluded. The label contraindicates implantation without an appropriate response to test stimulation, inability to operate the system and diathermy.[4]
PNE and staged tined-lead evaluation are alternative ways to document response. Duration and programming depend on the clinical plan and system instructions. The single-stage cost model and small case series leave the labeled test-response requirement in place.[5][6]
| Approach | Description | Reported data |
|---|---|---|
| PNE | Office test with a temporary wire near S3 | In one center, 35 of 76 (46%) screened by PNE met criteria for permanent implant[5] |
| Staged tined lead | Permanent tined lead placed in the operating room, external stimulator during a test period of at least 14 days | In the same center, 18 of 41 (44%) who failed PNE were implanted after a successful tined-lead test; no significant difference in long-term success was detected by screening method[5] |
| Single stage | Lead and generator implanted in one procedure | A 2019 cost-minimization model for refractory OAB using 2017 Medicare reimbursement found single-stage placement less costly above 61.3% success in outpatient hospital departments or 65.4% in ambulatory surgery centers; a 15-patient single-institution series reported 14/15 (93.3%) with at least 50% symptom improvement at median 14.6-month follow-up[6][29] |
In Medicare data for older women, staged implantation was associated with a 17% lower likelihood of any device-related reoperation than PNE or full implant.[19]
The 2024 AUA/SUFU OAB guideline states that clinicians should offer SNM, tibial nerve stimulation and/or intradetrusor botulinum toxin to patients with an inadequate response to, or intolerable side effects from, pharmacotherapy or behavioral therapy .[7] Clinicians may offer minimally invasive procedures, in the context of shared decision-making, without requiring prior behavioral, non-invasive or pharmacologic trials , and to patients unable or unwilling to undergo those therapies .[7] US labeling still specifies failure of or intolerance to conservative treatment and an appropriate test response.[4]
High-Yield Clinical Evidence
OAB and Non-Obstructive Retention
InSite's prospective study tested 340 people and implanted 272. At five years, success was 67% in a modified-completers analysis versus 82% among completers. Those percentages use different assumptions about missing follow-up. Neither is the success rate of all people initially considered for therapy. Among completers, mean reduction was 2.0 leaks per day in participants with UUI and 5.4 voids per day in those with urgency-frequency. The most common device-related adverse events were an undesirable change in stimulation (22%), implant-site pain (15%) and ineffectiveness of therapy (13%).[8]
A separate older worldwide study implanted 152 patients after testing, including 31 with retention. At five years, reported success was 68% for urge incontinence, 56% for urgency-frequency and 71% for retention.[9] In the retention cohort, catheterization frequency fell from 5.3 to 1.9/day on average. Mean volume per catheterization fell from 379.9 to 109.2 mL.[9] A single-center series of 217 patients (mean follow-up 46.9 months) reported success of about 70% for urgency incontinence, 68% for urgency-frequency and 73% for idiopathic retention, with cure rates of 20%, 33% and 58%.[30] Forty-one percent had at least one device- or treatment-related surgical reintervention.[30]
ROSETTA — SNM Versus Botulinum Toxin
ROSETTA compared SNM with 200 U onabotulinumtoxinA in women with refractory UUI.[10] At six months, toxin reduced daily UUI slightly more (3.9 versus 3.3 episodes; between-group difference 0.63), with more UTIs and temporary catheterization. The two-year extension evaluated clinical responders: data were available for 260/298, and mean UUI reduction did not differ significantly.[11] Recurrent UTI was more frequent after toxin (24% versus 10%).[10][11]
The ROSETTA trial used 200 U onabotulinumtoxinA[10], whereas the current BOTOX label recommends 100 U as the maximum dose for adult idiopathic OAB[41]; see the botulinum toxin hub for indication-specific dosing. At six months, treatment satisfaction and endorsement were higher with toxin, and the trial found no difference in perceived convenience, adverse effects or treatment preference. At two years, satisfaction and endorsement remained higher with toxin.[10][11]
The economic study compared two-stage SNM with 200 U onabotulinumtoxinA in 2018 US dollars. Two-year costs were $35,680 for SNM and $7,460 for toxin, and five-year modeled costs were $36,550 and $12,020. There was no difference in mean UUI reduction or QALYs at two years, and the authors concluded that SNM was not good value compared with toxin.[12]
Fecal Incontinence
ASCRS 2023 states that SNM may be considered a first-line surgical option for incontinent patients with and without sphincter defects .[13]
In the North American multicenter InterStim study, 120 patients were implanted after test stimulation (133 tested, 90% success).[24] At 12 months, 83% had therapeutic success (at least 50% fewer incontinent episodes per week) and 41% had complete continence.[24] Weekly episodes fell from 9.4 to 1.9.[24] At five years, 76 patients (63%) were followed.[31] Of 72 with data, 89% had at least a 50% improvement and 36% were fully continent, and 27 of 76 (35.5%) had a revision, replacement or explant.[31] In a French retrospective cohort of 360 implanted patients, 162 (45%) had a favorable outcome at ten years, with 23% lost to follow-up; the Kaplan–Meier estimate was 64%.[14] These are different estimands. A 2025 review of 36 long-term studies found benefits but judged all included studies at serious risk of bias and emphasized heterogeneous definitions.[14][15]
Neurological Disease and Other Off-Label Uses
AUA/SUFU 2021 states that clinicians may offer SNM to select NLUTD patients with urgency, frequency and/or UUI .[16] It also states that clinicians should not offer SNM to NLUTD patients with spinal cord injury or spina bifida .[16] Neither statement addresses stress incontinence. Manufacturer safety and effectiveness remain unestablished for urinary dysfunction of neurological origin, so selection requires explicit consideration of diagnosis, progression, MRI needs and alternative bladder management.[16][4]
A 2021 meta-analysis of neurogenic lower urinary tract dysfunction reported a pooled test-stimulation success of 66.2% (21 studies, 887 patients) and a pooled permanent-implant success of 84.2% (24 studies, 428 patients).[17] Included studies were mostly retrospective case series at substantial risk of bias. A 2025 meta-analysis of 15 studies (573 patients with neurogenic bladder or bowel dysfunction) reported improvements in voiding frequency, leakage episodes, bladder compliance and maximum detrusor pressure.[17][33]
High pooled success after permanent implantation can reflect selection of prior test responders.[17]
IC/BPS, chronic pain, constipation and sexual symptoms are outside labeled indications and have separate evidence. A 2017 meta-analysis of 17 studies (583 patients) with refractory IC/BPS reported reduced pelvic pain, frequency and nocturia; its pooled success rate of 84% (95% CI 76–91%) came from 10 studies (258 patients), largely small observational series of test responders.[34] For constipation, the 2015 Cochrane review, based on two trials, concluded that SNS did not improve symptoms.[18] The open-label No.2-Trial randomized 67 patients with refractory idiopathic slow-transit constipation and reported success (at least three defecations per week at 6 months) in 22 of 41 (53.7%) after SNM versus 1 of 26 (3.8%) with conservative treatment.[45]
Reintervention and Device Choice
Pain, altered stimulation, infection, lead problems, loss of benefit and battery depletion may require reprogramming or surgery. In 32,454 older Medicare women, the estimated cumulative eight-year device-related reoperation incidence was 43%; this included generator replacement as well as revision or removal.[19]
| Study | Population and follow-up | Reintervention |
|---|---|---|
| Medicare women 65 and older[19] | 32,454; cumulative incidence at 1, 3 and 8 years | 9.4%, 20% and 43% for any device-related reoperation, including generator replacement |
| Single-center urinary series[32] | 96 devices, median follow-up 50.7 months | 39% revision; 20.8% explantation; revision was 50% with the earlier lead model and 31% with the tined lead |
| Single-center urinary series[30] | 217 patients, mean follow-up 46.9 months | 41% at least one surgical reintervention |
| Single-center series[35] | 219 patients | 16% revision or explantation |
| Fecal incontinence systematic review[15] | 36 studies, 3,770 patients, at least 36 months | 35.2% revision; 19.7% explantation |
| French fecal incontinence cohort[14] | 360 patients, 10 years | 64.7% surgical revision; 26.1% explantation |
| US, Canadian and Australian fecal incontinence cohort, as summarized by ASCRS 2023[13] | 120 implanted; 76 followed at least 5 years | 27/76 (35.5%) needed at least one revision, replacement or explant |
In one single-center series of 127 patients (135 operations), the revision rate was 22% of operations, with 6.7% explantation. Reasons included no efficacy, lead migration, infection, pain, generator malposition and the wish for an MRI-compatible device. Revisions for complications were associated with lower BMI at revision and older age, and antimicrobial envelope use did not change complication rates.[36]
A single-center retrospective study of 246 OAB patients found more revisions with rechargeable devices (34% of 150 versus 13.5% of 96); charging difficulty accounted for 35.3% of rechargeable revisions.[20] In the prospective post-market ELITE study, 68 patients with OAB implanted with InterStim Micro after a successful test had a mean OAB-q HRQL improvement of 33 points at 3 months, and 5 of 68 (7.4%) had device-, procedure- or therapy-related adverse events.[43] In a 53-patient post-market fecal incontinence study of the same generator, the Cleveland Clinic Incontinence Score improved by a mean of 4 points at 3 and 6 months, with related adverse events in 18.9%.[44] In a single-center observational cohort of 38 patients with fecal incontinence implanted with InterStim Micro (28 as replacements for nonrechargeable devices), 37 completed interviews at 24 months or later. The results section reports device regret in 20 of 37 (54%), broader device-management difficulty in 96%, and connectivity problems in 75%; continence improvement was modest.[37]
Accessory Safety Notice
An April 2025 FDA recall concerned specified Enhanced Verify evaluation handsets, CFN HH90130FA, that could fail to communicate and interrupt evaluation therapy. The affected serial list and replacement instructions should be checked. This was an evaluation-handset action and not an instruction to explant functioning implanted InterStim systems.[21]
See also: Axonics, PTNS systems, Altaviva, Revi, eCoin.
References
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2. Medtronic. SureScan MRI Technology. US model/lead combinations and scanning precautions. MRI resource; complete current MRI manual library.
3. Medtronic. InterStim X and InterStim Micro systems. Current US product specifications. InterStim X; InterStim Micro.
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7. AUA/SUFU. Idiopathic Overactive Bladder Guideline, 2024. Statements 23–25. Unabridged guideline.
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20. Cohen T, Huang Z, Aalami-Harandi A, et al. Revision Rates for Rechargeable Versus Non-Rechargeable Sacral Neuromodulation Devices in the Management of Overactive Bladder. Neurourology and Urodynamics. 2025;44(5):1031-1035. doi:10.1002/nau.70053
21. FDA. Class 2 Device Recall: InterStim Enhanced Verify Evaluation Handset, CFN HH90130FA. Z-1704-2025, initiated April 3, 2025. Affected serials and corrective action.
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37. Okocha M, La Raja C, Nikolaou S, et al. Outcomes of Rechargeable Sacral Neuromodulation for Faecal Incontinence: A Single-Centre Observational Study. Colorectal Disease. 2025;27(12):e70344. doi:10.1111/codi.70344
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44. Elterman D, Murphy M, Krlin R, et al. "Post-Market Study Evaluating Performance of the Rechargeable InterStim Micro System in Fecal Incontinence Patients." Int Urogynecol J. 2025;36(4):913-921. doi:10.1007/s00192-025-06127-9
45. Heemskerk SCM, Dirksen CD, van Kuijk SMJ, et al. "Sacral Neuromodulation Versus Conservative Treatment for Refractory Idiopathic Slow-transit Constipation: The Randomized Clinical No.2-Trial." Ann Surg. 2024;279(5):746-754. doi:10.1097/SLA.0000000000006158