InterStim™ SureScan™ 978B128Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 00763000203726), received between Sep 1, 2020 and Apr 21, 2026 — classified as 28 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (22 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 25 most recent of 58 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2026Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY/BOWEL DYSFUNCTION; URGE INCONTINENCE IT WAS REPORTED THAT " PATIENT (PT) SAID A LITTLE WHILE BACK THEY HAD TO HAVE AN MRI DONE AND HEY NOTICED THE LEAD TO THEIR STIMULATOR HAD TO COME AND ATTACHED AND THEY HAD MAJOR ISSUES WITH THAT NOT BEING IN WORKING ORDER. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE. PT SAID THEY HAD SEEN A DOCTOR AT FIRST UROLOGY, DR WHO SENT THEM TO A DOCTOR TO PUT IT IN. CALL DISCONNECTED, CALLED PT BACK 2 CALL RECORDINGS, CALLED PATIENT BACK, NO ANSWER, LEFT MESSAGE TO CALL PATS IF THEY NEEDED FURTHER ASSISTANCE.

  Patient problems: Insufficient Information

  MAUDE report 24940846 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY/BOWEL DYSFUNCTION AND URGE INCONTINENCE IT WAS REPORTED THAT THEY WERE RETAINING BIG TIME. PATIENT SAID THEY WERE STILL GETTING UTIS AND WERE ON AN ANTIBIOTIC FOR IT. PATIENT MENTIONED THEY WENT 3 MONTHS WITHOUT A CATHETER BECAUSE IT WAS WORKING AND IT WASN'T WORKING. CALLER STATED THAT THE INS STOPPED WORKING OVER THE SUMMER. CALLER WENT ON TO SAY THAT THEY WERE SOMETIMES STILL RETAINING URINE WHICH IS CAUSING UTIS. CALLER STATED THAT LAST WEEK THEY WERE TAKEN TO THE HOSPITAL AND HAD ANOTHER UTI. CALLER STATED THAT THEY TOOK AN ULTRASOUND OF THE PATIENTS BLADDER AND IT WAS EMPTY , A FEW HOURS LATER THEY TOOK ANOTHER ULTRASOUND AND COULD SEE THAT THE PATIENT WAS RETAINING URINE. CALLER STATED THAT THE THERAPY WAS WORKING INTERMITTENTLY. AGENT ASKED IF PATIENT HAS HAD ANY FALLS OR TRAUMA TO THE AREA AND PATIENT SAID NO. PATIENT STATED THEY HAVE MADE ADJUSTMENTS TO THE STIMULATION ABOUT 5-6 TIMES , EVEN SOMETIMES WITH THE HELP OF TH EIR UROLOGIST. PATIENT CONFIRMED THEY WERE FEELING STIMULATION WHEN THEY ADJUST IT. AGENT REVIEWED THERAPY INFORMATION AND GENERAL PROGRAMMING

  Patient problems: Urinary Retention; Urinary Tract Infection

  MAUDE report 23375386 ↗
• MalfunctionAug 27, 2025Migration or Expulsion of Device; Therapy Delivered to Incorrect Body Area; Impedance Problem; Therapeutic or Diagnostic Output Failure; Migration or Expulsion of Device; Therapy Delivered to Incorrect Body Area; Impedance Problem; Therapeutic or Diagnostic Output Failure

  INFORMATION WAS RECEIVED FROM AN UNKNOWN SOURCE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING DISCOMFORT/SORENESS/PINCHING. SPOKE TO THE PATIENT (PT) ON (B)(6) 2025. THEY WERE HAVING HIP AND BUTTOCK SENSATION. SHE ALSO WAS LIMITED TO 0.3 MA ON MULTIPLE PROGRAMS INDICATING AN IMPEDANCE ISSUE. REPRESENTATIVE (REP) SENT AN EMAIL TO THE OFFICE THAT THEY MAY NEED AN XRAY TO CHECK THEIR LEAD AS REP INDICATED THERE WAS A LEAD MIGRATION.

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

  MAUDE report 22903540 ↗
• MalfunctionJul 8, 2024Difficult to Insert; Human-Device Interface Problem; Difficult to Insert; Human-Device Interface Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE 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 WHILE PLACING A NEW MRI-SAFE LEAD THE DAY OF THE REPORT, THEY WERE UNABLE TO GET THE INTRODUCER OVER THE GUIDEWIRE. NOTHING LOOKED VISIBLY WRONG WITH THESE COMPONENTS, BUT THEY WERE UNABLE TO ADVANCE THE INTRODUCER. THEY DID NOT HAVE A REVISION KIT AVAILABLE, SO HAD TO OPEN A NEW MRI-SAFE LEAD KIT. THE AFFECTED LEAD KIT WAS THROWN AWAY, AND THE NEW LEAD KIT WAS OPENED AND USED SUCCESSFULLY. THERE WERE NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS REPORTED AT THIS TIME. THE CALLER WAS TRANSFERRED TO CUSTOMER SERVICE TO GET A REPLACEMENT KIT. T HIS WAS AN OUT-OF-BOX (OOB) FAILURE. ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT THE CAUSE OF THE INABILITY TO GET THE INTRODUCER OVER THE GUIDEWIRE TO ADVANCE THE INTRODUCER WAS UNKNOWN. THE PHYSICIAN ALSO HAD NO EXPLANATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19695338 ↗
• MalfunctionMay 8, 2024Break; Migration or Expulsion of Device; Insufficient Device Problem Information; Break; Migration or Expulsion of Device; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION. IT WAS REPORTED THAT HCP WAS DOING A FULL IMPLANT ON THE PT. THE FIRST LEAD WAS INITIALLY IMPLANTED WHEN THE HCP WAS DEPLOYING THE TINES, THE LEAD SHIFTED TOWARDS S2. AT THIS POINT THE INTRODUCER WAS FULLY REMOVED. HCP TRIED TO ADJUST THE LEAD AFTER DEPLOYED WITH NO IMPROVEMENT IN RESPONSES. SHE TRIED TO REINSERT THE LEAD INTRODUCER SHEATH OVER THE LEAD TO MANIPULATE THE LEAD BACK IN PROPER POSITION. IN THE ATTEMPT TO DO THIS, THE INTRODUCER SHEATH BENT AND COULD NOT ADVANCE INTO FULLY INTO THE FORAMEN. HCP WAS CONCERNED THE LEAD WAS POSSIBLY DAMAGED BECAUSE OF THIS AND COMPLETELY REMOVED THE LEAD INTRODUCER SHEATH AND THE LEAD. DUE TO POSSIBLE RISK OF DAMAGED LEAD, REQUESTED TO OPEN A NEW LEAD KIT AND START OVER. THE NEW LEAD KIT USED WAS THE A NEW LEAD. THE NEW LEAD WAS PLACED WITHOUT INCIDENT. NO PATIENT HARM OR DAMAGE DONE AND PATIENT RESPONSES APPROPRIATE. REMOVED LEAD AND LEAD INTRODUCER WILL BE SENT BACK TOMORROW 4/25/24.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19273475 ↗
• InjuryApr 19, 2024Failure to Deliver Energy; Migration or Expulsion of Device; Unintended Collision; Energy Output Problem; Impedance Problem; Failure to Deliver Energy; Migration or Expulsion of Device; Unintended Collision; Energy Output Problem; Impedance Problem

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION (INCONTINENCE, URGENCY, AND/OR FREQUENCY) IT WAS REPORTED THAT PATIENT FELL IN JANUARY AND THEN COULDN'T INCREASE STIM PAST 0.7 AND THEIR SYMPTOMS GOT WORSE FROM THE LOSS OF THERAPY. REP INTERROGATED DEVICE AND FOUND THE SAME ISSUES, IMPEDANCE AT ELECTRODES 1 AND 3. IMAGING SHOWED LEAD WAS ALSO DISLODGED SO HCP REPLACED WITH NEW LEAD.

  Patient problems: Insufficient Information

  MAUDE report 19143720 ↗
• InjuryApr 3, 2024Unintended Collision; Energy Output Problem; Unintended Collision; Energy Output Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS IMPLAN TED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIM. IT WAS REPORTED THAT THE PATIENT HAD A  RETURN OF BASELINE SYMPTOMS - URINARY INCONTINENCE. PATIENT REPORTED FALLING (B)(6) WHILE CARRYING A BUNCH OF GROCERIES. AFTER ATTEMPTS TO REPROGRAM PATIENT AND HCP AGREED ON A REPLACEMENT.

  Patient problems: Incontinence

  MAUDE report 19035826 ↗
• InjuryFeb 1, 2024Migration or Expulsion of Device; Unstable; Migration or Expulsion of Device; Unstable

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTED NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIM AND GASTROINTESTINAL/PELVIC FLOOR THERAPY. THE REP REPORTED THAT THE INS AND THE LEAD MOVED, AND IT WAS EXPLANTED. THE DOCTOR THOUGHT MAYBE THE DEVICE HAD GREATLY MOVED OUT OF PLACE OR FLIPPED MANY TIMES. THE REP REPORTED THAT THE CAUSE WAS UNKNOWN. A NEW LEAD AND IPG AND TYRX WERE PLACED ON (B)(6) 2023

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18623800 ↗
• MalfunctionJan 24, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). THE REP REPORTED THAT THE STYLET AND "BLUE FIN" DID NOT SEEM TO ALIGN. [SEE SIMILAR REPORTED EVENT REPORTED IN 706180200].

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18576602 ↗
• MalfunctionJan 24, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE REP STATES THAT THE 'CURVE' WAS NOT LINED UP WITH THE 'LITTLE BLUE FIN' ON THE STYLET THAT THEY USE AS A GUIDE TO DETERMINE HOW LATERAL THEY ARE GOING--WHEN THEY INSERTED IT 'DIDN'T SEEM ALIGNED'. THE REP STATES THEY DIDN'T NECESSARILY HAVE ISSUES BEYOND WHAT WAS NOTED HERE. THE REP DOES HAVE THE STYLET FOR THIS CASE THEY WILL SEND BACK. [SEE SIMILAR REPORTED EVENT REPORTED IN (B)(4)]

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18576509 ↗
• InjuryDec 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. THEY REPORTED THAT THEY WENT TO THE ER DUE TO PAIN GENERALLY ALL OVER AND THEY BELIEVED IT WAS THE INS POSSIBLY CAUSING IT. THEY STATED THAT THE PAIN ALL OVER STARTED ON WEDNESDAY AND THEY HAD PREVIOUSLY TURNED OFF THE LEFT IMPLANT. THEY WERE INSTRUCTED TO TURN OFF THE RIGHT IMPLANT AS WELL AND SEEK MEDICAL ATTENTION. THEY WOULD ALSO NOTIFY THEIR MD PER THE AGENTS SUGGESTION. ON 2024-MAR-30 THEY CALLED BACK TO INFORM THAT THEIR IMPLANTS HAD BEEN EXPLANTED ON FRIDAY DUE TO CONTINUING PAIN ISSUE.

  Patient problems: Numbness; Pain

  MAUDE report 18336870 ↗
• InjuryNov 13, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION. IT WAS REPORTED THAT THE PATIENT DID GREAT AT THE STAGE 1 AND NEARLY IMMEDIATELY AFTER THEIR STAGE 2 THEY RETURNED TO THEIR BASELINE SYMPTOMS. THE HCP SENT THEM FOR FILMS WHICH SHOWED LEAD MIGRATED DEEPER. REPROGRAMMING WAS DONE AT THAT TIME AND THE PATIENT ONLY ACHIEVED 20% IMPROVEMENT. PATIENT DENIES FALLS OR ACCIDENT OR ANY OBVIOUS INCIDENT THAT COULD HAVE CAUSED MIGRATION. THE LEAD WAS REMOVED AND REPLACED SUCCESSFULLY. IT WAS REPORTED THAT THE ISSUE WAS RESOLVED.

  Patient problems: Incontinence; Micturition Urgency; Urinary Frequency / Polyuria

  MAUDE report 18120127 ↗
• InjuryMar 27, 2023Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE STYLET WAS NOT IN THE LEAD, AND THE LEAD WAS ALREADY PLACED. THE REP WANTED TO KNOW IF THE LEAD SHOULD BE PULLED.  THE LEAD WAS PULLED AND A NEW LEAD WAS USED. ON (B)(6) 2023 ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). THE REP REPORTED THAT TO CLARIFY, THE THAT THE BLUE STYLET PART (THE PIECE ON THE END) WASN¿T THERE, ONLY THE WHITE PLASTIC BETWEEN ELECTRODES WHEN THEY WENT TO PULL OUT THE INTRODUCER. THE STYLET WAS NOT PRELOADED WHEN IT CAME OUT OF THE KIT. THE HCP WENT TO BRING THE INTRODUCER OUT AND NO STYLET WAS THERE. THE LEAD WENT IN FINE, BUT BECAUSE THEY WEREN¿T SURE WHAT HAPPENED TO THE STYLET, THEY PULLED THE LEAD AND PLACED A NEW ONE FROM A NEW KIT. IN REFERENCE TO WANTING AN X-RAY, IT WAS TO MAKE SURE THERE WAS NOTHING IN THE LEAD, BUT IT WAS NOT NEEDED SINCE THE REPLACED THE LEAD. THE REP SAID THAT THE ORIGINAL LEAD WENT IN FINE AND TESTED FINE. THEY REMOVED THAT LEAD AND USED A NEW OUT OF CAUTION JUST IN CASE THERE WAS SOMETHING LEFT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16622931 ↗
• InjuryMar 8, 2023Break; Connection Problem; Break; Connection Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. IT WAS REPORTED THAT THE CAUSE OF THE LEAD STRIPPING WAS DUE TO THE UNCONNECTED PERCUTANEOUS CONNECTOR BEING PULLED WITHOUT BEING DISCONNECTED PRIOR. THE PHYSICIAN INSTRUCTED THE CIRCULATING NURSE TO PULL THE PERCUTANEOUS EXTENSION WITHOUT DISCONNECTING IT FROM THE LEAD THAT WAS IN THE POCKET. THE PHYSICIAN ALSO HAD A SURGICAL TOOL IN THE POCKET TO TRY AND ENLARGE THE POCKET FOR THE INS. THE NURSE PULLING THE PERCUTANEOUS EXTENSION DRUG THE LEAD ACROSS THE PHYSICIAN TOOL AND STRIPPED A PORTION OF THE LEAD. THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16506205 ↗
• MalfunctionJan 26, 2023Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT THAT WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY/BOWEL DYSFUNCTION AND URGE INCONTINENCE. IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE TIP OF LEAD INTRODUCER BROKE OFF DURING REMOVAL. THE CAUSE IS UNKNOWN. TROUBLESHOOTING WAS PERFORMED. THE SURGEON USED A CLAMP TO GET IT OUT OF THE PATIENT'S BODY. THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16250797 ↗
• MalfunctionNov 8, 2022Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR FECAL INCONTINENCE. IT WAS REPORTED THAT WHEN THE DILATOR WAS INSERTED OVER THE GUIDE WIRE IT MUST HAVE SHEARED ON THE PATIENT¿S CALCIFIED FORAMEN CAUSING THE RADIOPAQUE MARKER TO COME OFF AND REMAIN IN PATIENT. WHEN WE USED A NEW SHEATH AND INSERTED THE LEAD THE LEADS SEEM TO NOT HAVE ANY RESPONSES. THEY TRIED NEW SHEATH AND LEAD. CAUSE WAS NOT KNOWN.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15755425 ↗
• MalfunctionOct 31, 2022Connection Problem; Connection Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR FECAL INCONTINENCE. IT WAS REPORTED THAT THE J CABLE WOULD NOT CONNECT TO THE ENS. A SECOND ENS WAS ATTEMPTED. WHEN THE CABLE STILL WOULD NOT CONNECT, A NEW LEAD WITH CABLE WAS OPENED AND THE NEW CABLE CONNECTED WITHOUT ISSUE. THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15698934 ↗
• MalfunctionOct 27, 2022Failure to Deliver Energy; Migration or Expulsion of Device; Failure to Deliver Energy; Migration or Expulsion of Device

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP). THE REP RECEIVED A MESSAGE FROM THE DOCTOR TO CALL THE PATIENT FOR REPROGRAMMING. THE PATIENT IS UNABLE TO FEEL STIMULATION. THE PATIENT HAD AN X-RAY ON MONDAY, (B)(6) 2022 , AND IT WAS CONFIRMED THAT THE LEAD HAD MIGRATED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15680458 ↗
• InjurySep 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A PATIENT WITH AN EXTERNAL NEUROSTIMULATOR (ENS) FOR URGENCY FREQUENCY. THE TRIAL BEGAN (B)(6) 2022. IT WAS REPORTED THAT THERE WAS A SUSPECTED INFECTION. THE PATIENT WAS EXPERIENCING REDNESS, FLUID DISCHARGE, AND PUS DISCHARGE. ANTIBIOTICS WERE ORDERED. THERE IS A STRONG CHANCE THE LEAD WILL BE REMOVED (B)(6) 2022. THE PATIENT'S DSG AT THE EXTENSION EXTERNALIZATION SITE WAS FALLING OFF. THE PATIENT TRIED TO REINFORCE IT WITH TAPE. TODAY, THE PATIENTS DSG WAS CHANGED IN THE OFFICE AND APPEARED TO BE INFECTED (RED, SWOLLEN, DISCHARGE) ON THE SKIN AROUND THE EXTENSION EXIT SITE. THE AREA WAS CLEANED AND REDRESSED. PLAN FOR POTENTIAL REMOVAL ON MONDAY AND PATIENT PUT ON ANTIBIOTICS.

  Patient problems: Erythema; Fluid Discharge; Purulent Discharge; Unspecified Infection

  MAUDE report 15485637 ↗
• InjuryAug 11, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTED NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR. . IT WAS REPORTED THAT THE SHEATH COVERING THE INTERNAL WIRES SEPARATED AT THE POINT WHERE THE LEAD WAS INSERTED INTO THE CONNECTOR WHILE THE DOCTOR WAS ATTEMPTING TO FIND THE CONNECTOR TO THE PERCUTANEOUS EXTENSION. THE CAUSE WAS NOT KNOWN. WHILE THE DOCTOR WAS PERFORMING THE STAGE 2 PROCEDURE THEY WERE HAVING ISSUES LOCATING THE PERCUTANEOUS EXTENSION CONNECTOR. WHEN PULLING ON THE LEAD THE SHEATH COVERING THE INTERNAL WIRES BROKE AND EXPOSED THE INTERNAL WIRES. THE HCP DECIDED TO REMOVE THE LEAD COMPLETELY AND REPLACE IT. THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15209090 ↗
• MalfunctionMay 19, 2022Break; Material Deformation; Break; Material Deformation

  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 THE LEAD WAS NEVER IMPLANTED, IT WAS BENT DURING THE PROCEDURE. IT WAS UNKNOWN WHAT TROUBLESHOOTING WAS PERFORMED AND THE CAUSE OF THE LEAD BEING BENT WAS UNKNOWN. IT WAS REPORTED THE ISSUE WAS RESOLVED. NO PATIENT SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14434102 ↗
• MalfunctionApr 13, 2022Failure to Deliver Energy; Human-Device Interface Problem; Insufficient Device Problem Information; Failure to Deliver Energy; Human-Device Interface Problem; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE MANUFACTURER REPRESENTATIVE (REP) CALLED TO REPORT AN INTRA-OP LEAD ISSUE. REP SAID ACCOUNT CLAIMS THAT 978B1 LEAD USED DURING STAGE 1 EVALUATION WAS FAULTY AS THE PATIENT WAS NOT SHOWING ANY MOTOR RESPONSES ONCE IT WAS IMPLANTED AND TESTED. LOT NUMBER OF THE LEAD IS VA2F5NL AND CAME IN LEAD KIT 3560022. REP IS GOING TO SEND THE LEAD BACK FOR ANALYSIS.

  Patient problems: Insufficient Information

  MAUDE report 14104409 ↗
• InjuryApr 4, 2022Unintended Collision; Unintended Collision

  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 HAD PAIN WITH INCREASE IN STIMULATION. THE PATIENT FELL, THE HCP TRIED TROUBLESHOOTING. LEAD REVISION WAS DONE, WHOLE LEAD REMOVED AND NEW LEAD PLACED. THE ISSUE WAS RESOLVED AT TIME OF REPORT.

  Patient problems: Pain

  MAUDE report 13994320 ↗
• InjuryFeb 21, 2022Break; Positioning Problem; Break; Positioning Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS UNDERGOING AN IMPLANT FOR AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR GASTROINTESTINAL /PELVIC FLOOR THERAPY. IT WAS REPORTED THAT  THE PHYSICIAN TRIED TO GET THE LEAD TO CORRECTLY DEPLOY, BUT WAS UNABLE, THEY TRIED REPOSITIONING THE LEAD SEVERAL TIMES. THE LEAD CONTINUED TO LOOK AWKWARD WHEN PICTURES WERE TAKEN UNDER FLUORO, THE LEAD APPEARED CRACKED ON DISTAL END.  THE HCP HAD TO REMOVE IT AND USE A DIFFERENT LEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13571326 ↗
• InjuryFeb 2, 2022Failure to Deliver Energy; High impedance; Unintended Collision; Failure to Deliver Energy; High impedance; Unintended Collision

  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 STATED THAT THEY FELL AT WORK AND EVER SINCE THEIR SYMPTOMS HAVE NOT BEEN CONTROLLED. IMPEDANCE TEST AND ALL ELECTRODES WERE GREATER THAN 4000. THEY TURNED STIM OFF AND PHYSICIAN AWARE. THE PATIENT HAS AN UNRELATED MEDICAL HISTORY OF MULTIPLE SCLEROSIS.

  Patient problems: Insufficient Information

  MAUDE report 13425020 ↗

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