InterStim™ SureScan™ 978A128Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00763000203603), received between Feb 11, 2021 and May 10, 2022 — classified as 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 reports).

7 other recalls cover devices cleared under the same FDA submission (P080025, P970004); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 10, 2022Failure to Deliver Energy; Failure to Deliver Energy

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE PATIENT WAS NOT EXHIBITING ANY RESPONSES TO THE STIMULATION. ENSURED ALL CONNECTIONS WERE MADE, TESTING ON CORRECT PART OF NEEDLE, PATIENT DID NOT RECEIVE PARALYTICS. PHYSICIAN REQUESTED A NEW TEST STIMULATION CABLE. HAD TO OPEN NEW LEAD KIT. OPENED NEW LEAD KIT TO REPLACE TEST STIMULATION CABLE AND THE ISSUE WAS RESOLVED AT TIME OF REPORT.

  Patient problems: Insufficient Information

  MAUDE report 14347204 ↗
• InjuryJan 24, 2022Therapy Delivered to Incorrect Body Area; Insufficient Device Problem Information; Therapy Delivered to Incorrect Body Area; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE PATIENT'S RECHARGING TIME WAS LENGTHY SO A POCKET REVISION WAS SCHEDULED. THE PATIENT COMPLAINED IN PRE-OP FOR THE POCKET REVISION THAT THEIR SYMPTOM IMPROVEMENT HADN'T BEEN GREATER THAN 50% AND THE STIMULATION THEY DID FEEL WAS IN THEIR LEG. THE PATIENT DENIES ANY FALLS OR ANY TRAUMA THAT WOULD HAVE AFFECTED THE POCKET OR THE LEAD. DURING THE POCKET REVISION PROCEDURE, THEY TESTED THE EXISTING LEAD, AND MOTOR RESPONSE WAS NO BELLOWS WITH STRONG TOE. IMAGE ON FLUOROSCOPY SHOWED THE DEPTH OF THE TINED LEAD BEING TOO DEEP AND ALL ELECTRODES WERE LOCATED PAST THE ANTERIOR PORTION OF THE SACRUM. THE TINES WERE STRADDLED BETWEEN THE SACRUM. ONE TINE WAS BELOW THE ANTERIOR PORTION OF THE SACRUM AND THE OTHER WAS SLIGHTLY ABOVE THE SACRUM. THE LEAD WAS REPLACED AND HAD BELLOW AND TOE MOTOR RESPONSE AND WAS PLACED AT APPROPRIATE DEPTH. THE BATTERY WAS REPOSITIONED TO BE PARALLEL TO THE SKIN IN ORDER FOR THE BATTERY TO PAIR WITH THE RECHARGER.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Undesired Nerve Stimulation

  MAUDE report 13335155 ↗
• MalfunctionJan 14, 2022Human-Device Interface Problem; Insufficient Device Problem Information; Human-Device Interface Problem; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT WHEN DOCTOR PULLED LEAD OUT OF POCKET TO DISCONNECT FROM THE EXTENSION , THE LEAD JUST SLID OUT OF THE EXTENSION HUB WITHOUT USE OF THE TORQUE WRENCH. THE IMPEDANCE CHECK IN PRE-OP YIELDED ALL GREEN IMPEDANCES AND PATIENT FELT STIM IN ANUS AND LOW BUTTOCKS AT LESS THAN 1.0MA THROUGHOUT THE TRIAL ON SEVERAL DIFFERENT PROGRAMS; STAGE 2 LEAD PULL TODAY (B)(6); STAGE 1 LEAD IMPLANT WAS (B)(6). TRIAL WAS FROM (B)(6) TO (B)(6); USAGE GRAPH ON ENS SHOWED PATIENT HAD THERAPY ON 24 HOURS/DAY. THERE WAS NO SURGICAL INTERVENTION THAT OCCURRED. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13259099 ↗
• InjuryNov 4, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT DURING POST-OP. IT WAS REPORTED THAT THE CHRONIC LEAD OF THE PATIENT WAS DISPLACED.  IT WAS A NON-WORKABLE LEAD BECAUSE OF DISPLACEMENT.  THE PHYSICIAN REMOVED THE LEAD.  NO FURTHER INFORMATION WAS REPORTED REGARDING THE EXPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12752400 ↗
• InjuryAug 12, 2021Difficult to Insert; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Difficult to Insert; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR. IT WAS REPORTED THAT AFTER THE GUIDE WIRE HAD BEEN PLACED POSITION BEGAN TO INSERT THE LEAD INTRODUCER, IT WAS ALMOST IMPOSSIBLE TO GET THE INTRODUCER INTO THE FORAMEN. SHE TOOK THE INTRODUCER OUT TRIED TO PLACE THE LEAD, LEAD WOULD NOT SLIDE INTO PLACE. SHE TOOK EVERYTHING OUT. RELOADED THE INTRODUCER TRIED TO RE-INSERT AND WAS UNABLE TO INSERT IT. IT WAS REMOVED, THE SECOND TIME THE PLASTIC PART OF THE INTRODUCER WAS COMPLETELY DESTROYED. PHYSICIAN DID NOT USE THE INTRODUCER INAPPROPRIATELY, SHE FOLLOWED PROCEDURE EXACTLY. AT THAT TIME IT WAS DECIDED A NEW INTRODUCER KIT HAD TO BE OPENED, NEW INTRODUCER SLID IN PERFECTLY IMPLANT WENT GREAT. NO SYMPTOMS WERE REPORTED. THE ISSUE WAS CONFIRMED RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12312346 ↗
• MalfunctionAug 10, 2021High impedance; Connection Problem; High impedance; Connection Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIM AND GASTROINTESTINAL/PELVIC FLOOR THERAPY. IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A STAGE 1 RC INTERSTIM PROCEDURE DUE TO URGENCY FREQUENCY BLADDER SYMPTOMS. LEAD 978A128 IMPLANTED - LEFT SACRAL. LEAD TUNNELED TO RIGHT SIDE BUTTOCK-POCKET. PERCUTANEOUS EXTENSION CABLE (3560030/VA276GM) TUNNELED TO RIGHT SIDE POCKET. LEAD ELECTRODES WIPED DRY. LEAD CONNECTED TO PERC EXT CABLE. SECURED WITH ONE SET SCREW. POCKET SUTURED CLOSED. PHYSICIAN ADDED A STITCH WHERE THE PERC EXT CABLE EXITS THE BODY. ENS CONNECTED TO PERC EXT CABLE. ENHANCED VERIFY CONTROLLER (EVC) USED TO CONFIRM CONNECTION. OPENED ¿CONFIGURATION¿. APP RUNS IMPEDANCE CHECK AUTOMATICALLY. IMPEDANCE SHOWN IN ELECTRODE 3 ONLY. SINCE POCKET WAS ALREADY SUTURED CLOSED, DECIDED TO PROGRAM AROUND IMPEDANCE. PROGRAMMED EVC. OPENED MYTHERAPY APP. SET TO C3 - WAS ABLE TO RAISE AND LOWER STIMULATION IN MYTHERAPY APP. ENS TAPED TO LEFT SIDE BUTTOCK. RE-TESTED CONNECTION IN MYTHERAPY APP. PATIENT SET ON C3/0.1MA IN PREPARATION TO RAISE THE STIMULATIO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12305274 ↗
• InjuryJun 8, 2021Break; Break

  INFORMATION WAS RECEIVED FROM AN UNKNOWN SOURCE REGARDING A PATIENT WHO WAS UNDERGOING A STAGE 2 PROCEDURE TO BE IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIM AND GASTROINTESTINAL/PELVIC FLOOR THERAPY. IT WAS REPORTED THAT WHEN THE HEALTHCARE PROFESSIONAL (HCP) AND REP OPENED THE POCKET FOR STAGE 2, THE PHYSICIAN NOTICED THE SHEATH ON THE LEAD APPEARED WEAKENED AT ONE POINT AND SLICED IN ANOTHER EVEN THOUGH THE WIRE WAS STILL ATTACHED. THE PHYSICIAN DID USE SCISSORS TO GET THE INSIDE STITCHES OUT AND SAID THAT THEY MAY HAVE ACCIDENTALLY CAUGHT THE LEAD. THEY THEN REMOVED THE CUT LEAD COMPLETELY, AND REPLACED THE LEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11958663 ↗
• MalfunctionMay 27, 2021Material Twisted/Bent; Material Twisted/Bent

  ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). THE REP REPORTED THAT THEY DID NOT SEE THE BENT TIP BEFORE IT WAS OPENED. BOTH THE REP AND IMPLANTER NOTICED THE ISSUE WHEN THE LEAD WOULDN'T GO IN RIGHT. THERE WAS NO APPARENT DAMAGE TO THE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11894731 ↗
• MalfunctionFeb 11, 2021Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS UNDERGOING AN IMPLANT PROCEDURE FOR AN ADVANCED EVALUATION TRIAL. IT WAS REPORTED THAT THE LEAD INTRODUCER BROKE DURING THE PROCEDURE. THEY REPLACED THE LEAD INTRODUCER DURING THE PROCEDURE. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11314343 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P080025, P970004. One submission often covers many models, so check the product and lot details in each record.

• Z-1704-2025 · Apr 3, 2025 · Open, Classified
  Enhanced Verify Evaluation Handset (CFN HH90130FA)
• Z-0372-2025 · Sep 18, 2024 · Open, Classified
  Medtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components WR9230 and WR9220A Recharger for rechargeable implantable neurostimulators. The Rechargers are used wi
• Z-2365-2023 · Jul 6, 2023 · Open, Classified
  Medtronic InterStim Ground Pad REF 041826
• Z-0998-2022 · Feb 28, 2022 · Terminated
  MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL, which includes the following: a) Handset with Communicator, Model Numbers: 1) TH90Q01, 2) TH90QFA, 3) TH90PFA, 4) TH90GFA,
• Z-1147-2015 · Jan 9, 2015 · Terminated
  The Medtronic, Quadripolar ITREL 3 IPG, Model 7425, is a multiprogrammable device designed for use in the Stimulation of the Central Nervous System, Peripheral Nervous System, or m
• Z-0037-2008 · Jun 25, 2007 · Terminated
  Medtronic InterStim II INS Model 3058 with N'Vision InterStim-B Software supplied on the Model 8870 Version MMB_01/NNB_01 N'Vision with a Clinic an Programmer Model 8840. Implanta
• Z-0040-2008 · Jun 25, 2007 · Terminated
  Medtronic InterStim INS (Model 3023) with N'Vision Inter Stim-B software supplied on the Model 8870 Version MMB_01/NNB_01 with N'Vision Clinician Programmer Model 8840 or InterStim