INTERSTIM® 3889-28 (UDI 00643169887923)Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00643169887923), received between Oct 20, 2017 and May 27, 2025 — classified as 8 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Break” (13 reports).

5 other recalls cover devices cleared under the same FDA submission (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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryMay 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A LEAD REMAINING AND WERE HAVING SURGERY ON (B)(6) 2025 TO ATTEMPT TO HAVE IT REMOVED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22087870 ↗
• MalfunctionSep 22, 2021Break; Break

  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 THE HEALTHCARE PROVIDER FRACTURED THE LEAD DURING REMOVAL PROCEDURE. THE HEALTHCARE PROVIDER DID MASSAGE AND DISSECT WHEN REMOVING THE LEAD, BUT IT FRACTURED. THEY USED FLOURO TO TRY TO REMOVE THE FRACTURED LEAD, BUT THE ISSUE WAS NOT RESOLVED. THE LEAD WAS REPLACED WITH AN MRI COMPATIBLE LEAD, BUT A PARTIAL LEAD REMAINED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12512460 ↗
• MalfunctionSep 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use 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. IT WAS REPORTED THAT THE PATIENT WAS HAVING THEIR SYSTEM REMOVED TO HAVE AN MRI, AND A FRAGMENT OF THE LEAD WAS LEFT IN THE FORAMEN.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10602702 ↗
• InjurySep 3, 2020Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM 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 THE DOCTOR ATTEMPTED TO REMOVE THE LEAD DURING A REPLACEMENT AND THE LEAD FRACTURED, LEAVING 4 ELECTRODES. THE DOCTOR ATTEMPTED TO DISSECT DOWN THE FORAMEN TO REMOVE THE FRACTURED ELECTRODES, BUT WAS NOT ABLE TO DO SO. IT WAS REPORTED THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10487559 ↗
• InjuryApr 8, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR (INS) FOR GASTROINTESTINAL/PELVIC FLOOR AND URINARY DYSFUNCTION/SACRAL NERVE STIM. IT WAS REPORTED THAT THE PATIENT CAME IN FOR A STAGE 2 AFTER 21 DAY TRIAL. THE UROLOGY COORDINATOR MESSAGED THE MANUFACTURER REPRESENTATIVE AND SAID THEY PULLED THE LEAD DUE TO IT NOT BEING IN S3. THE LEAD WAS ORIGINALLY PLACED USING OPTIMAL LEAD PLACEMENT TECHNIQUE. THE LEAD WAS PULLED DUE TO ALLEGED MIGRATION DESPITE STILL RECEIVING OVER 50% EFFICACY IMPROVEMENT. THERE WERE NO SYMPTOMS REPORTED BY THE PATIENT THAT WOULD INDICATE THAT THIS LEAD HAD MIGRATED. THE PATIENT WAS STILL HAVING GREATER THAN 50% EFFICACY. THE ISSUE WAS RESOLVED AT THE TIME OF THIS REPORT. NO FURTHER PATIENT COMPLICATIONS ARE ANTICIPATED OR EXPECTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9935917 ↗
• MalfunctionFeb 25, 2020Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR. THE PATIENT WAS SCHEDULED FOR A REPLACEMENT, LEAD BROKE OFF ABOVE TINES LEAVING THE 4 ELECTRODES UP TO THE TINES WHEN PHYSICIAN WAS REMOVING THE LEAD FROM THE BODY. NEW LEAD WAS PLACED ON THE OTHER SIDE. NO TROUBLESHOOTING PERFORMED. THE DEVICE WAS NOT RETURN-CUSTOMER REFUSED. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. NO FURTHER PATIENT COMPLICATIONS ARE ANTICIPATED OR EXPECTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9750276 ↗
• MalfunctionFeb 17, 2020Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER¿S REPRESENTATIVE (REP). WHEN ASKED FOR THE CAUSE OF THE LEAD BREAKING THE REP INDICATED THE LEAD WAS BROKEN DURING THE REMOVAL PROCESS AS THE PHYSICIAN WAS PULLING ON IT TO REMOVE IT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9716590 ↗
• MalfunctionFeb 14, 2020Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR. PATIENT SAID THEY HAD A PORTION OF THE SYSTEM EXPLANTED AND X-RAYS SHOW THE LEAD OR PORTION OF THE LEAD REMAINS IMPLANTED. CALLER INDICATED THE REASON FOR REMOVAL OF THE DEVICE WAS FOR MRI COMPATIBILITY AND IS CALLING ABOUT GUIDELINES. THE CALLER ALSO INDICATED THE REMOVAL OCCURRED A COUPLE OF DAYS AGO. THE CALL CENTER REVIEWED MRI COMPATIBILITY INFORMATION WITH THE HCP. ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTH CARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE. IT WAS REPORTED THAT A PORTION OF THE LEAD WAS LEFT BEHIND; IT BROKE DURING EXPLANT AND NO CAUSE WAS DETERMINED. IT WAS NOTED THAT NO EXPLANT OF THE PARTIAL LEAD IS SCHEDULED OR PLANNED. NO FURTHER PATIENT COMPLICATIONS ARE ANTICIPATED OR EXPECTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTH CARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE. IT WAS REPORTED THAT THE PATIENT TOLD THEIR PA THAT THEY HAD IT REMOVED, BUT THE PATIENT¿S MANAGING HEALTHCARE PROVIDER HAD NO RECORD OF REMOVING I

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9711748 ↗
• InjuryJan 10, 2020Break; Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Break; Difficult to Remove; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED BY A MANUFACTURE REPRESENTATIVE (REP) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR. IT WAS REPORTED THAT THE PATIENT HAD A LEAD FRACTURE DUE FROM FLIPPING IN THE POCKET AND HAD A RETURN OF SYMPTOMS. AN INTERVENTION WAS REQUIRED TO REPLACE THE LEAD. THE HEALTHCARE PROVIDER (HCP) ATTEMPTED TO REMOVE FRACTURED LEAD BUT IN THE ATTEMPT TO BRING IT BACK TO MIDLINE, THE LEAD BROKE AND THE HCP WAS UNABLE TO FIND THE END. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 9577918 ↗
• MalfunctionJan 3, 2019Peeled/Delaminated; Peeled/Delaminated

  INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL, VIA THE MANUFACTURER¿S REPRESENTATIVE, REGARDING A PATIENT IMPLANTED FOR A STAGE 1 TRIAL EVALUATION. IT WAS REPORTED THAT THE INSULATION ON THE LEAD SEPARATED FROM THE LEAD AT THE EXTENSION CONNECTOR SITE. SPECIFICALLY, WHEN THEY WENT TO EXCHANGE THE EXTENSION FOR THE BATTERY, IT WAS FOUND THAT THE INSULATION HAD SEPARATED FROM THE LEAD. THE PHYSICIAN FELT THE PATIENT HAD LIKELY BEEN PULLING ON THE EXTENSION DURING THE TRIAL, THUS COMPROMISING THE LEAD. AS A FACTOR THAT MAY HAVE LED TO THE ISSUE, THE PHYSICIAN STATED CONCERNS FOR PATIENT COMPLIANCE AND THAT THE PATIENT HAD BEEN PULLING OR MESSING WITH THE LEAD. NO DIAGNOSTICS OR TROUBLESHOOTING WERE PERFORMED. THE PHYSICIAN CHOSE TO EXPLANT DUE TO PATIENT COMPLIANCE CONCERNS, AN INCREASED RISK OF INFECTION, AND THEIR REPEATED REQUESTS FOR ADDITIONAL PAIN MEDICATION. NO ACTIONS/INTERVENTIONS WERE TAKEN TO RESOLVE THE ISSUE. THE ISSUE WAS RESOLVED AT THE TIME OF REPORT. THE PATIENT STATUS WAS NOTED AS ¿ALIVE ¿ NO INJURY¿. THERE WERE NO FURTHER COMPLICATIONS REPORTED OR ANTICIPATED.

  Patient problems: Pain

  MAUDE report 8212222 ↗
• MalfunctionSep 14, 2018Break; Difficult to Insert; Adverse Event Without Identified Device or Use Problem; Positioning Problem; Break; Difficult to Insert; Adverse Event Without Identified Device or Use Problem; Positioning Problem

  INFORMATION WAS RECEIVED BY A HEALTH CARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT AN ELECTRODE REMAINED IN PATIENT'S BODY AFTER EXPLANT, AND WAS DETERMINED BY FLUOROSCOPY. IT WAS FURTHER REPORTED THERE WAS A LEAD INSERTION ISSUE AND IT WAS UNCERTAIN WHETHER IT WAS A TECHNIQUE ISSUE OR A POTENTIAL ISSUE WITH THE PATIENT'S SCLERODERMA. PATIENT WAS ABLE TO PLACE THE NEEDLE IN THE CORRECT LOCATION AND INSERTED THE DIRECTIONAL GUIDEWIRE AND WAS ABLE TO GET TO THE CORRECT LOCATION AND EVEN HAD TO PULL IT BACK SLIGHTLY IN THE PATIENT. THEN, THEY PLACED THE LEAD INTRODUCER BUT WHEN THEY WERE HALF WAY THROUGH THE SACRUM AND TRIED TO INTRODUCE THE LEAD, THE LEAD WOULD NOT PASS ALL THE WAY THROUGH. THEY TRIED MOVING THE NEEDLE DEEPER BUT STILL WOULD NOT ADVANCE. IT WAS DETERMINED THAT THE LEAD HAD CURVED UP INTO THE FORAMEN AND WHEN THEY TRIED TO REMOVE THE LEAD, THE 3RD CONTACTED STAYED IN THE PATIENT. THE DOCTOR TRIED A SECOND TIME AND HAD THE SAME RESULT THAT THEY COULD NOT ADVANCE THE LEAD BUT WERE ABLE TO REMOVE THE LEAD WITH NO ISSUES AND THE SECOND LEAD WAS INTACT. IT WAS NOTED THEY TRIED BOTH THE STRAIGHT AND CURVED STYLET BUT COULD NOT ADVANCE THE L

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7877077 ↗
• InjurySep 5, 2018Energy Output Problem; Energy Output Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR (INS) FOR GASTROINTESTINAL/PELVIC FLOOR AND URINARY DYSFUNCTION/SACRAL NERVE STIM. IT WAS REPORTED THAT THE LEAD WAS PLACED MULTIPLE TIMES AND APPEARED ANATOMICALLY CORRECT, MEDIAL/SUPERIOR IN THE S3 FORAMINA. AFTER MULTIPLE TESTS AND A LENGTHY PERIOD OF TIME, THE DECISION WAS MADE TO TRY A NEW LEAD WIRE. THEY ATTEMPTED TO USE A NEW TEST CABLE, TEST BOX, AND GROUNDING PAD. THE NEW LEAD WAS PLACED IN THE SAME LOCATION, CONFIRMED VIA X-RAY, AND ALL OF THE ELECTRODES TESTED APPROPRIATELY; THE PATIENT DEMONSTRATED A BELLOWS AND TOE RESPONSE AT 1.0 ON ALL 4 ELECTRODES. THE ISSUE WAS NOTED TO BE RESOLVED. ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE. IT WAS REPORTED THAT AFTER IMPLANTING THE LEAD SEVERAL TIMES, THEY COULD NOT GET A CONSISTENT RESPONSE. AT THAT TIME, THEY EXCHANGED THE GROUND PAD, TEST CABLE, AND TEST BOX, BUT NONE OF THOSE CHANGES HELPED SO THEY DECIDED TO USE A NEW LEAD WIRE. NO FURTHER PATIENT COMPLICATIONS ARE ANTICIPATED OR EXPECTED AS A RESULT OF THIS EVENT.

  Patient problems: Therapeutic Effects, Unexpected

  MAUDE report 7847082 ↗
• MalfunctionJul 31, 2018Device Contamination with Body Fluid; Device Contamination with Chemical or Other Material; Insufficient Device Problem Information; Device Contamination with Chemical or Other Material; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED BY A HEALTH CARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT DURING STAGE 1 AND 2, BLOOD GOT INSIDE THE TINED LEAD BEFORE DEPLOYING THE TINES AND THE LEAD WAS NEVER IMPLANTED. THE DOCTOR SUSPECTED THE POSSIBILITY OF THE LEAD BEING FAULTY OR COMPROMISED AND CHOSE TO GET A BRAND NEW LEAD TO IMPLANT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7734555 ↗
• MalfunctionJun 28, 2018Break; Device Or Device Fragments Location Unknown; Break; Device Or Device Fragments Location Unknown

  INFORMATION WAS RECEIVED FROM A CONSUMER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH A PERCUTANEOUS LEAD. [RELEVANT MEDICAL HISTORY: PATIENT HAD INTERSTIM IN THE PAST] IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN IN THEIR BUTTOCKS AND DOWN THEIR LEG. THE PATIENT'S STIMULATION WAS OFF AT THE TIME OF THE REPORT BECAUSE THE PHYSICIAN CUT THE PERCUTANEOUS EXTENSION WIRE AND THE PATIENT HAD NOT YET PROCEEDED TO STAGE 2. STAGE 2 WAS SCHEDULED FOR A LATER DATE, BUT THE LEAD REMAINED IMPLANTED AND WAS NOT ACTIVE. CONTRIBUTING FACTORS TO THE REPORTED EVENT WERE UNKNOWN. THE PHYSICIAN'S ASSISTANT HAD ADMINISTERED ANTI-INFLAMMATORY MEDICATIONS, BUT THE PATIENT DID NOT GET RELIEF. IT WAS REPORTED THAT THE ISSUE WAS UNRESOLVED AT THE TIME OF THE REPORT. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

  Patient problems: Pain

  MAUDE report 7646192 ↗
• MalfunctionJun 7, 2018Component Missing; Device Operates Differently Than Expected; Component Missing; Device Operates Differently Than Expected

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER¿S REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPL ANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE BENT TIP STYLET WAS MISSING THE TOP PART OF THE WHITE PLASTIC WHERE IT ATTACHES TO THE LEAD, THE PLASTIC CONNECTOR. THE LEAD WAS REMOVED FROM THE FIELD AND A NEW ONE WAS OPENED FOR THE PROCEDURE. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7578808 ↗
• InjuryApr 2, 2018Break; Peeled/Delaminated; Break; Peeled/Delaminated

  ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE. IT WAS REPORTED THAT THE HEALTHCARE PROVIDER NOTICED THE DEFECT WHEN CONNECTING THE LEAD TO THE CONNECTOR AFTER TUNNELING. THE NEW LEAD HAD TO BE RE-TUNNELED. THE CAUSE OF THE LEAD SEPARATING FROM THE INSULATION WAS NOT KNOWN. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7388543 ↗
• InjuryDec 14, 2017High impedance; Device Operates Differently Than Expected; High impedance; Device Operates Differently Than Expected

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR (INS) FOR GASTROINTESTINAL/PELVIC FLOOR AND URINARY DYSFUNCTION/SACRAL NERVE STIM. IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, THE IMPEDANCE WAS READING OVER 4000 OHMS ON CONTACT 0. IT WAS NOTED THAT ALL OTHER CONTACTS WERE GOOD. THE HIGH IMPEDANCE PERSISTED DESPITE TROUBLESHOOTING EFFORTS, SO THE PERCEIVED DEFECTIVE LEAD WAS UNABLE TO BE IMPLANTED. THE PATIENT WAS SUCCESSFULLY IMPLANTED WITH A DIFFERENT LEAD. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7118563 ↗
• MalfunctionDec 5, 2017Break; Device Operates Differently Than Expected; Break; Device Operates Differently Than Expected

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR (INS) FOR GASTROINTESTINAL/PELVIC FLOOR AND URINARY DYSFUNCTION/SACRAL NERVE STIM. IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE PHYSICIAN TRIED TO LOAD THE CURVED STYLET INTO THE LEAD AND THE HEAD OF THE STYLET BROKE IN TWO, MAKING THE STYLET INOPERABLE. NO ENVIRONMENTAL, EXTERNAL, OR PATIENT FACTORS CONTRIBUTED TO THE ISSUE. A NEW LEAD AND STYLET WERE OPENED AND USED SUCCESSFULLY TO COMPLETE THE IMPLANT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7082546 ↗
• InjuryDec 4, 2017Break; Peeled/Delaminated; Break; Peeled/Delaminated

  THE PATIENT WAS HAVING SURGERY TO GO FROM THE ADVANCED EVALUATION (STAGE 1) TO THE STAGE 2 IMPLANTATION OF BATTERY TO THE IMPLANTED LEAD. WHILE THE PHYSICIAN WAS SLIDING THE BOOT AWAY FROM THE LEAD EXTENSION IT WAS NOTICED THAT THE INSULATION WAS PULLED BACK AWAY FROM THE PROXIMAL END OF THE LEAD WHERE IT CONNECTS TO CONTACTS ON THE LEAD'S PROXIMAL END. THE BARE WIRE WAS EXPOSED, AND THE INSULATION WOULD NOT RETRACT BACK OVER THE EXPOSED WIRES. THE PHYSICIAN OPTED TO CHANGE THE LEAD BY EXPLANTING THE LEAD USED FOR THE ADVANCED EVALUATION (STAGE 1) AND IMPLANTING A NEW LEAD, CONNECTING THE NEW LEAD TO AN IMPLANTABLE NEUROSTIMULATOR (INS) COMPLETING THE FULL IMPLANT. THE PATIENT HAD A GOOD THERAPY RESULT POST OP WITH STIMULATION FELT IN THE VAGINAL AREA. SURGICAL INTERVENTION WAS PERFORMED AND LEAD WAS EXPLANTED COMPLETELY. THE LEAD WILL BE RETURNED. NO DIAGNOSTICS PERFORMED BECAUSE THERE WAS NOTHING TO BE DONE. THE ISSUE REPORTED WAS RESOLVE AT THE TIME OF THIS REPORT. THE PATIENT INDICATORS FOR USE ARE FOR URINARY DYSFUNCTION/SACRAL NERVE STIM AND GASTROINTESTINAL/ PELVIC FLOOR. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7079152 ↗
• MalfunctionNov 5, 2017Break; Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A TRIAL PATIENT. IT WAS REPORTED THAT THE ELECTRODES WERE FOUND TO BE DAMAGED AFTER THE LEAD WAS REMOVED FROM THE LEAD EXTENSION SET SCREW HOUSING. PATIENT COMPLIANCE WAS LIKELY THE CAUSE. THE LEAD WAS DAMAGED BELOW THE BLUE MARKS OF THE PROXIMAL END OF THE LEAD AND THE SURGEON DEEMED IT UNUSABLE. ANOTHER LEAD PLACEMENT WAS ATTEMPTED BUT THE TINES WERE DEPLOYED BEFORE THE MOTOR RESPONSE COULD BE REFINED. THE CASE OF CANCELLED AND PATIENT WILL BE RESCHEDULED FOR FULL IMPLANT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7002293 ↗
• MalfunctionOct 23, 2017Break; Break

  INFORMATION WAS RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE REGARDING A TRIAL PATIENT IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE LEAD APPEARED TO GET CAUGHT ON THE BONE ON THE ANTERIOR FORAMEN AND THE DOCTOR WAS CONCERNED IT BECAME DAMAGED. A NEW LEAD WAS THEN OPENED AND USED AND THE PROCEDURE CONTINUED AS PLANNED. THE ISSUE WAS REPORTED AS RESOLVED AT THE TIME OF REPORT. THE PATIENT STATUS WAS NOTED AS ¿ALIVE ¿ NO INJURY¿. THERE WERE NO FURTHER COMPLICATIONS REPORTED OR ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6968305 ↗
• MalfunctionOct 20, 2017Unsealed Device Packaging; Device Damaged Prior to Receipt by User; Device Operates Differently Than Expected; Unsealed Device Packaging; Device Damaged Prior to Receipt by User; Device Operates Differently Than Expected

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS BEING IMPLANTED WITH A NEUROSTIMULATOR. IT WAS REPORTED THAT THE STERILE PACKAGING OF THE LEAD LOOKED COMPROMISED. ALTHOUGH IT WAS NOT OPENED, IT APPEARED THERE WAS SLIGHT WATER DAMAGE ON THE TYVEK COMPONENT OF THE PACKAGING. THE HEALTHCARE PROFESSIONAL (HCP) MADE THE DECISION TO USE THE LEAD AND, ONCE IT WAS DEPLOYED IN THE PATIENT, THEY TESTED THE ELECTRODES LOOKING FOR PATIENT SENSORY AND MOTOR RESPONSE. THE 3 AND 2 ELECTRODES SEEMED TO WORK AND PRODUCED THE APPROPRIATE RESPONSES, BUT THE 1 AND 0 ELECTRODES DID NOT GARNER A RESPONSE FROM THE PATIENT. A DECISION WAS MADE TO OPEN A NEW LEAD AND THE PROBLEM WAS RESOLVED. THERE WERE NO SYMPTOMS OR FURTHER COMPLICATIONS REPORTED OR ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6965744 ↗

Recalls under the same FDA submission

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

• 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-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