InterStim™ 306001 (UDI 00763000114077)Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00763000114077), received between Jun 3, 2020 and Aug 16, 2022 — classified as 1 injury, 26 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 16, 2022Break; Human-Device Interface Problem; Insufficient Device Problem Information; Break; Human-Device Interface 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 UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT DURING PROCEDURE LEAD STYLET APPEARS TO COME OUT THROUGH ELECTRODE. THE LEAD WAS DISCARDED AND NEW LEAD WAS USED. THE REPORTED ISSUE WAS RESOLVED AT THE TIME OF THE INCIDENT. THERE WAS NO SURGICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15232626 ↗
• MalfunctionAug 4, 2022Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS IMPLAN TED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT SURGEON WENT TO USED THE BASIC EVALUATION LEAD AND NOTICED THAT IT WAS FAULTY. THE BOTTOM OF THE LEAD HAD COME AWAY FROM THE TIP AND COULD NOT BE USED. ANOTHER LEAD WAS ISSUED AND USED. THIS ONE WAS ALSO FAULTY IN THE SAME MANNER. LEADS DISCARDED AND THIRD LEAD OPENED AND USED SUCCESSFULLY. THE ISSUE WAS RESOLVED. NO SYMPTOMS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15165036 ↗
• MalfunctionAug 4, 2022Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS IMPLAN TED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT SURGEON WENT TO USED THE BASIC EVALUATION LEAD AND NOTICED THAT IT WAS FAULTY. THE BOTTOM OF THE LEAD HAD COME AWAY FROM THE TIP AND COULD NOT BE USED. ANOTHER LEAD WAS ISSUED AND USED. THIS ONE WAS ALSO FAULTY IN THE SAME MANNER. LEADS DISCARDED AND THIRD LEAD OPENED AND USED SUCCESSFULLY. THE ISSUE WAS RESOLVED. NO SYMPTOMS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15164976 ↗
• MalfunctionMar 28, 2022Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR ENS FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THERE WERE NO PATIENT ISSUES. WHEN PROVIDER OPENED SECOND LEAD KIT FOR BE, LEAD WAS UNUSABLE. TIP WAS EXPOSED AND FRAYED AT THE END, NOT RIGID AT ALL (FLOPPY). REP PROVIDED BE LEAD FROM THEIR TRUNK STOCK AND SUBMITTED PAPERWORK TO GIVE AT NO CHARGE. REPLACEMENT OF DEFECTIVE ITEM. THE ISSUE WAS CONFIRMED RESOLVED. NO PATIENT/SYMPTOMS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13928022 ↗
• MalfunctionFeb 24, 2022Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A TRIAL LEAD. IT WAS REP ORTED THAT PNE LEAD, LOOKING DISFORMED AT THE DISTAL END. THE REP DISCUSSED THAT THIS CAN HAPPEN IF THE EXTERNAL PART OF THE LEAD IS PULLED OVER THE STYLET. WILL REPLACE THE FAULTY LEADS, WITH BACKUP TO ENSURE THAT THERE IS NO RISK OF PATIENTS BEEN CANCELLED. THE ISSUE WAS CONFIRMED RESOLVED. NO SYMPTOMS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). THE REP REPORTED THAT THE ISSUE WAS DISCOVERED PRIOR TO USE AND THE LEADS WERE NEVER IMPLANTED. THE CAUSE WAS HARD TO TELL, IT COULD HAVE BEEN USER ERROR OR IF IT WAS LIKE THIS OUT OF THE PACK. THE CUSTOMER JUST WANTED TO RECORD THAT THERE WERE ISSUES WITH THIS LOT OF PNE LEADS, SO THAT IT COULD BE LOOKED AT IF OTHER ACCOUNTS HAD REPORTED ISSUES. THE REP WOULD BE SPENDING TIME WITH THE HCP NEXT WEEK TO LOOK AT ANY POSSIBLE TRAINING REQUIREMENTS TOO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13591938 ↗
• MalfunctionAug 12, 2021Material Perforation; Positioning Problem; Insufficient Device Problem Information; Material Perforation; Positioning Problem; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP: INDICATION FOR USE WAS TO TREAT OAB- FREQUENCY AND URGE INCONTINENCE. OUT OF BOX DEFECT FOR LEAD WAS NOTICED. THE LEAD HAS BEEN DISCARDED BY MISTAKE PER ACCOUNT. DIFFERENT LEAD WAS IMPLANTED FOR TEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12312856 ↗
• MalfunctionAug 10, 2021Break; Difficult to Remove; Break; Difficult to Remove

  ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP). THE HCP REPORTED THAT THE CAUSE OF THE LEAD STRETCHING WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12300890 ↗
• InjuryJul 13, 2021Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR URGE INCONTINENCE, URGENCY FREQUENCY. IT WAS REPORTED THAT DURING REMOVAL OF THE STYLET TO LEAVE LEAD IN PLACE THE LEAD SHREDDED DESPITE THE PHYSICIAN GENTLY HOLDING IT. HE HAD ALREADY COMPLETED THE ONE SIDE WITHOUT ISSUE. NO FACTORS WERE REPORTED. PHYSICIAN WAS GENTLE WITH LEAD AND HAD EVEN DONE THE OTHER SIDE WITHOUT ISSUE. THE LEAD SHREDDED (UNCOILED COMPLETELY) DURING REMOVAL SO PHYSICIAN DECIDE TO REMOVE, REPLACE NEEDLE, THEN TRY LEAD PLACEMENT AGAIN DURING THE PNE. REPLACED FORAMEN NEEDLE THEN USED A NEW LEAD FOR PLACEMENT WITH SUCCESS SO PATIENT COULD BE EVALUATED ON BOTH SIDES. THE ISSUE WAS CONFIRMED RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12160370 ↗
• MalfunctionMay 17, 2021Difficult to Insert; Difficult to Insert

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR UNKNOWN INDICATION FOR USE; THE TRIAL BEGAN ON (B)(6) 2021. IT WAS REPORTED THAT THE 306001 PNE LEAD'S INNER STYLET WAS STICKING THROUGH THE DISTAL PART OF THE LEAD COILS. THIS DEFECT PREVENTED THE LEAD TO FEED THROUGH THE CANULA OF THE FORAMEN NEEDLE. THE PHYSICIAN TRIED TO ADJUST THE INNER STYLET SO THAT IT DID NOT STICK THROUGH THE SIDE OF THE LEAD. THIS DID NOT WORK. NO ENVIRONMENTAL/EXTERNAL/ OR PATIENT FACTORS LED OR CONTRIBUTED TO THE ISSUE. OPENED A NEW 306001 PNE LEAD AND DID NOT USE THE DEFECTIVE LEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11832793 ↗
• MalfunctionFeb 22, 2021Difficult to Remove; Difficult to Remove

  INFORMATION WAS RECEIVED FROM A MANUFACTURE REPRESENTATIVE REGARDING A PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE STYLET DID NOT DETACH FROM THE LEAD PROPERLY. THE BLUE SILICONE AT THE PROXIMAL END. A REPLACEMENT LEAD WAS USED SUCCESSFULLY AND THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11357956 ↗
• MalfunctionFeb 10, 2021Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS). IT WAS REPORTED THAT THE TRIAL PATIENT'S LEAD STYLET WAS NOT ABLE TO BE REMOVED FROM LEAD INTRA-OPERATIVELY. THE PHYSICIAN WAS NOT ABLE TO REMOVE THE STYLET FROM THE LEAD. THE DEFECTIVE LEAD WAS REMOVED FROM THE FORAMEN NEEDLE A SECOND LEAD WAS OPENED AND INSERTED. THE ISSUE WAS RESOLVED AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11308540 ↗
• MalfunctionJan 8, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE LEAD WOULD NOT FEED INTO THE STYLET. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11142440 ↗
• MalfunctionNov 18, 2020Positioning Problem; Insufficient Device Problem Information; Positioning Problem; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) REGARDING A LEAD FOR A BASIC EVALUATION. THEY REPORTED THAT THE STYLET KEPT GETTING STUCK IN THE LEADS AND COULDN'T BE USED. THE STYLET WOULD NOT ALLOW FOR THE LEAD TO BE PLACED PROPERLY. NO PATIENT SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10860108 ↗
• MalfunctionNov 4, 2020Break; Stretched; Break; Stretched

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS). IT WAS REPORTED THAT THE BE LEAD LOST INTEGRITY WHILE THE HEALTHCARE PROFESSIONAL WAS INSERTING IT INTO THE FORAMEN NEEDLE. A NEW LEAD WAS OPENED AND THE ISSUE WAS RESOLVED. ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP). IT WAS CLARIFIED THAT THE LEAD BECAME STRETCHED, AND LOST DEXTERITY/WAS DAMAGED WHILE TRYING TO INSERT THE LEAD INTO THE FORAMEN NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10788279 ↗
• MalfunctionNov 3, 2020Difficult to Insert; Device Damaged Prior to Receipt by User; Material Twisted/Bent; Insufficient Device Problem Information; Difficult to Insert; Device Damaged Prior to Receipt by User; Material Twisted/Bent; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A BASIC EVALUATION TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR UNKNOWN PELVIC HEALTH INDICATIONS. IT WAS REPORTED THAT THE LEAD KINKED AND WAS UNABLE TO BE STRAIGHTENED OUT. THE KINK IN THE BOTTOM OF THE LEAD PREVENTED IT FROM BEING ABLE TO BE INSERTED INTO THE FORAMEN NEEDLE. THE PHYSICIAN TRIED TO PULL BACK ON THE LEAD TO GET THE STYLET TO STRAIGHTEN OUT AT THE BOTTOM OF THE LEAD, BUT WERE UNABLE TO REMEDY THE ISSUE INTRA-OPERATIVELY, SO A NEW LEAD WAS OPENED. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. THERE WERE NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS REPORTED AT THIS TIME. ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE (REP). THE REP CLARIFIED THAT THERE WERE TWO LEADS THAT HAD THE SAME ISSUE (A KINK IN THE BOTTOM WHICH PREVENTED INSERTION INTO THE FORAMEN NEEDLE). THE PHYSICIAN THOUGH THESE WERE OUT OF BOX ISSUES, BUT IT WAS NOT KNOWN FOR SURE. WHEN ASKED IF THE CAUSE OF THE KINKED LEAD HAD BEEN DETERMINED, THEY REPLIED, "NO," AND WHEN ASKED WHAT MOST LIKELY CAUSE OR CONTRIBUTED TO THE ISSUE, THEY RESPONDED IT WAS UNKNOWN, BU

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10780373 ↗
• MalfunctionOct 14, 2020Difficult to Insert; Device Damaged Prior to Receipt by User; Material Perforation; Difficult to Insert; Device Damaged Prior to Receipt by User; Material Perforation

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A BASIC EVALUATION TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR UNKNOWN PELVIC HEALTH INDICATIONS. IT WAS REPORTED THAT BOTH LEADS HAD THE STYLETS GO THROUGH THE LEAD AND THEY WERE UNABLE TO GET THEM THROUGH THE TESTING NEEDLES. THEY CAME OUT OF THE PACKAGE THAT WAY, AND THEY TRIED TO RELOAD THE STYLETS CORRECTLY INTO THE LEAD, BUT IT DID NOT WORK. DIFFERENT LEADS WERE USED AND THEY WORKED, SO THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. THERE WERE NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS REPORTED AT THIS TIME. ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). THE REP REPORTED THAT THE PATIENT'S SYMPTOM THE DEVICE WAS INTENDED TO TREAT WAS URGE INCONTINENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10680185 ↗
• MalfunctionOct 14, 2020Difficult to Insert; Device Damaged Prior to Receipt by User; Material Perforation; Difficult to Insert; Device Damaged Prior to Receipt by User; Material Perforation

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A BASIC EVALUATION TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR UNKNOWN PELVIC HEALTH INDICATIONS. IT WAS REPORTED THAT BOTH LEADS HAD THE STYLETS GO THROUGH THE LEAD AND THEY WERE UNABLE TO GET THEM THROUGH THE TESTING NEEDLES. THEY CAME OUT OF THE PACKAGE THAT WAY, AND THEY TRIED TO RELOAD THE STYLETS CORRECTLY INTO THE LEAD, BUT IT DID NOT WORK. DIFFERENT LEADS WERE USED AND THEY WORKED, SO THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. THERE WERE NO PATIENT SYMPTOMS, OR FURTHER COMPLICATIONS REPORTED AT THIS TIME. ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). THE REP REPORTED THAT THE PATIENT'S SYMPTOM THE DEVICE WAS INTENDED TO TREAT WAS URGE INCONTINENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10680173 ↗
• MalfunctionAug 10, 2020Difficult to Remove; Difficult to Remove

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A BASIC EVALUATION TRIAL PATIENT. THE REP REPORTED THAT INTRA-OPERATIVELY, THE STYLET BECAME STUCK UPON REMOVAL. THE PHYSICIAN TRIED A NUMBER OF TIMES TO REMOVE IT, BUT FOR SOME REASON IT BECAME STUCK. THE ISSUE WAS RESOLVED BY REPLACING THE LEAD. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10386031 ↗
• MalfunctionAug 10, 2020Break; Material Perforation; Break; Material Perforation

  NO NEW INFORMATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10384232 ↗
• MalfunctionJul 27, 2020Difficult to Insert; Stretched; Difficult to Insert; Stretched

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT UNDERGOING A BASIC EVALUATION TRIAL. THE REP REPORTED THAT THE EVALUATION LEAD WAS STRETCHED OUT TOO FAR THAT THE LOADED STYLET WOULD NOT GO BACK IN. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). THE REP REPORTED THAT THERE WAS NO PATIENT SYMPTOMS/HARM THAT OCCURRED IN RELATION TO THE EVENT. THE REP CLARIFIED THAT THE LEAD WAS STRETCHED OUT TOO FAR AND WOULD NOT RETURN TO IT'S ORIGINAL LENGTH. THE CAUSE OF THE LEAD STRETCHING WAS REPORTED TO BE DUE TO PHYSICIAN HANDLING. A NEW LEAD HAD BEEN SUCCESSFULLY IMPLANTED AT THE TIME OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10328413 ↗
• MalfunctionJul 24, 2020Stretched; Stretched

  INFORMATION WAS RECEIVED FROM MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN TRIAL DEVICE (ENS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIM AND GASTROINTESTINAL/PELVIC FLOOR THERAPY IT WAS REPORTED THE EVALUATION LEAD WAS STRETCH OUT TOO FAR THAT THE LOADED STYLET WOULD NOT GO BACK IN. NO SYMPTOMS REPORTED AND NO FURTHER COMPLICATION NOTED OR ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10321086 ↗
• MalfunctionJul 17, 2020Difficult to Remove; Stretched; Insufficient Device Problem Information; Difficult to Remove; Stretched; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER¿S REPRESENTATIVE (REP) REGARDING A PATIENT UNDERGOING A BASIC EVALUATION TRIAL FOR GASTROINTESTINAL /PELVIC FLOOR THERAPY. IT WAS REPORTED THAT THE NEW TRIAL LEAD WOULD NOT CLEAR WHEN TRYING TO PULL OUT THE STYLET, BUT INSTEAD IT SEEMS LIKE IT GOT STUCK AND STRETCHED OUT RENDERING IT USELESS FOR THE EVALUATION. NOTHING COULD BE DONE TO SAVE THE LEAD. SOMETHING SEEMED TO SNAG AND THUS STRETCH OUT THE LEAD. ANOTHER LEAD WAS PLACED SO THE PATIENT REMAINS UNAFFECTED AND THE ISSUE WAS RESOLVED. NO FURTHER COMPLICATIONS WERE REPORTED OR ARE ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10292038 ↗
• MalfunctionJul 17, 2020Difficult to Insert; Device Damaged Prior to Receipt by User; Material Twisted/Bent; Difficult to Insert; Device Damaged Prior to Receipt by User; Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER¿S REPRESENTATIVE (REP) REGARDING A PATIENT UNDERGOING A TRIAL FOR EXTERNAL NEUROSTIMULATOR (ENS). IT WAS REPORTED THAT THE END OF LEAD TIP KINKED. IT WAS REPORTED THE HCP ATTEMPTED RESEATING THE LEAD, LEAD WOULD NOT POUCH THROUGH FORAMEN NEEDLE. THEY USED ANOTHER LEAD AND IT WORKED FINE. THERE IS NO PATIENT INVOLVED IN THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED OR ARE ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10288947 ↗
• MalfunctionJul 15, 2020Break; Material Perforation; Break; Material Perforation

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER¿S REPRESENTATIVE (REP) REGARDING A PATIENT UNDERGOING A TRIAL FOR EXTERNAL NEUROSTIMULATOR (ENS) FOR GASTROINTESTINAL/PELVIC FLOOR THERAPY. IT WAS REPORTED THE HCP ATTEMPTED TO INSERT LEAD INTO FOREMEN NEEDLE BUT WAS UNABLE TO, AND THE STYLET HAD GONE THROUGH THE PNE LEAD AND THEY WERE UNABLE TO PLACE THE LEAD INTO THE NEEDLE. THEY USED ANOTHER LEAD AND IT WORKED FINE. NO PATIENT INJURY WAS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED OR ARE ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10276213 ↗
• MalfunctionJun 26, 2020Difficult to Insert; Insufficient Device Problem Information; Difficult to Insert; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER¿S REPRESENTATIVE (REP) REGARDING A PATIENT UNDERGOING A TRIAL FOR GASTROINTESTINAL /PELVIC FLOOR THERAPY. IT WAS REPORTED ONE OF THE NEW BASIC EVALUATION LEADS MALFUNCTIONED DURING PNE PROCEDURE. THE LEAD WOULD NOT ADVANCE THRU THE FOREMEN NEEDLE. THEY USE A DIFFERENT LEAD FOR PLACEMENT AND THE ISSUE WAS RESOLVED. NO SYMPTOMS REPORTED NO FURTHER COMPLICATIONS NOTED OR ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10202634 ↗

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