INTERSTIM® 305901 (UDI 00643169721166)Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00643169721166), received between Jul 25, 2017 and Jun 18, 2020 — classified as 3 injuries, 22 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 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 18, 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, AND THE STYLET BROKE THROUGH THE SIDE OF THE PNE LEAD. NO PATIENT INJURY WAS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED OR ARE ANTICIPATED

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10168097 ↗
• MalfunctionMay 22, 2020Break; Material Twisted/Bent; Break; Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A LEAD. IT WAS REPORTED THAT DURING THE PROCEDURE THE TIP OF THE LEAD CURVED WHEN REMOVED FROM THE SHEATH. NO ATTEMPT HAD BEEN MADE TO USE THE PRODUCT ON THE PATIENT. CONTRIBUTING FACTORS WERE UNKNOWN. THE LEAD WAS INSPECTED CLOSELY BY THE PHYSICIAN AT THE STERILE FIELD. THE IMPLANTING PHYSICIAN WAS NOT COMFORTABLE USING THE LEAD DUE TO UNUSUAL CURVE AT TIP, SO A NEW LEAD WAS OPENED TO BE IMPLANTED IN THE PATIENT. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10082231 ↗
• MalfunctionFeb 28, 2020Material Twisted/Bent; Material Twisted/Bent

  ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). IN RESPONSE TO THE INQUIRY OF DEVICE RETURN STATUS, THE REP PROVIDED A TRACKING NUMBER AND REPORTED THAT THE LEAD HAD BEEN RETURNED EARLIER THAT DAY ON (B)(6) 2020.

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

  MAUDE report 9769562 ↗
• MalfunctionJan 28, 2020Break; Difficult to Remove; Stretched; Positioning Problem; Break; Difficult to Remove; Stretched; Positioning Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS). THE HCP REPORTED THAT DURING AN IMPLANT PROCEDURE, SHE ENTERED THE NEEDLE INTO THE S3 FORAMEN. WHEN TRYING TO RETRACT THE NEEDLE FROM THE SKIN, SHE NOTICED THE LEAD WOULD NOT STAY IN THE SKIN. IT WAS REPORTED THAT IT WAS LIKE THE LEAD WAS CAUGHT INSIDE OF THE NEEDLE. THE HCP REMOVED THE ENTIRE LEAD/NEEDLE COMBO AND TRIED TO PULL THE LEAD OUT OF THE NEEDLE BUT WAS UNSUCCESSFUL AND THIS CAUSED THE LEAD TO STRETCH. THE LEAD/NEEDLE COMBO WAS SENT FOR ANALYSIS. A SECOND LEAD WAS USED AND WAS PLACED WITH NO ISSUE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9638094 ↗
• MalfunctionJan 3, 2020Device Damaged Prior to Receipt by User; Material Twisted/Bent; Device Damaged Prior to Receipt by User; Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS). IT WAS NOTED THAT THE PATIENT¿S TRIAL STARTED ON (B)(6) 2019. IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN ATTEMPTING TO PLACE THE SECOND LEAD, IT WAS DETERMINED THAT THE TIP OF THE LEAD WAS BENT. IT WAS NOTED THAT NO ENVIRONMENTAL/EXTERNAL OR PATIENT FACTORS WERE DETERMINED, AS THE LEAD APPEARED BENT AS SOON AS IT WAS REMOVED FROM ITS PLASTIC SHEATH. THEY ATTEMPTED TO ADJUST THE STYLET WITHIN THE LEAD WITHOUT REMOVING IT COMPLETELY, HOWEVER, IT DID NOT CHANGE THE SIGNIFICANT BEND IN THE LEAD. IT APPEARED AS IF THE LEAD TIP WAS BENT OVER ON ITSELF AND THAT THE STYLET HAD PUSHED THROUGH THE LEAD ITSELF. A NEW LEAD WAS THEN OPENED AND ABLE TO BE SUCCESSFULLY PLACED WITH NO ISSUES. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9546062 ↗
• MalfunctionSep 17, 2019Stretched; Stretched

  INFORMATION WAS RECEIVED BY A MANUFACTURE REPRESENTATIVE (REP) WHO CONFIRMED THE INFORMATION WITH THE HEALTHCARE PROVIDER (HCP) REGARDING A LEAD AS NURSE PRACTITIONER (NP) WAS REMOVING THE FORAMEN NEEDLE, THE LEAD BECAME CAUGHT IN FORAMEN NEEDLE WHICH CAUSED THE LEAD TO STRETCH AND PULL. THE CAUSE OF THE ISSUE WAS NOT DETERMINED. THE ACTION/INTERVENTION TAKEN TO RESOLVE THE ISSUE WAS A NEW LEAD WAS OPENED AND USED. THE LEAD WAS DISCARDED IN BETWEEN PROCEDURES BEFORE THE REP COULD REMOVE IT FROM THE ACCOUNT. NO PATIENT SYMPTOMS WERE REPORTED AND NO FURTHER COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9075024 ↗
• MalfunctionSep 13, 2019Device Damaged Prior to Receipt by User; Material Deformation; Material Twisted/Bent; Device Damaged Prior to Receipt by User; Material Deformation; Material Twisted/Bent

  ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). THE CAUSE OF THE BENT LEAD AND STYLET WAS NOT DETERMINED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9050456 ↗
• InjuryAug 26, 2019Material Deformation; Positioning Problem; Material Deformation; Positioning 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 LEAD STRETCHED OUT WHEN PULLING OUT OF NEEDLE. THE LEAD WAS DISCARDED AND THE ISSUE WAS RESOLVED. NO SYMPTOMS WERE REPORTED AND NO FURTHER COMPLICATIONS WERE NOTED OR ANTICIPATED

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8930159 ↗
• MalfunctionJun 26, 2019Break; Difficult to Remove; Break; Difficult to Remove

  INFORMATION WAS RECEIVED BY A TRIAL PATIENT REGARDING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR URGE INCONTINENCE. PATIENT STATED SHE HAD SUCH A HEADACHE AND HAS BEEN NAUSEATED. PATIENT STATED HER SHE IS NOT VOIDING AS MUCH AS WELL. PATIENT ADVISED TO CONTACT HER CLINICIAN. STYLET WOULDN¿T PULL OUT FROM PNE LEAD. THERE WAS NONE EXTERNAL OR ENVIRONMENTAL FACTORS TO HAVE OCCURRED. PHYSICIAN TRIED TO PULL IT OUT FOR SEVERAL MINUTES BEFORE IT EVENTUALLY BROKE. AFTER IT BROKE, THE STYLET RETRACTED BACK INTO THE LEAD. WE RETESTED THE LEAD WITH GOOD RESULTS, SO PHYSICIAN DECIDED TO LEAVE AS WAS AFTER DETERMINING IT WOULDN¿T AFFECT HOOK UP TO THE EXTENSION. THERE WAS NO SURGICAL INTERVENTION PLANNED OR DONE. THE ISSUE WAS RESOLVED AT THE TIME OF THIS EVENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8733451 ↗
• MalfunctionFeb 26, 2019Break; Stretched; Material Twisted/Bent; Insufficient Device Problem Information; Break; Stretched; Material Twisted/Bent; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A MANUFACTURE REPRESENTATIVE (REP) REGARDING A PROCEDURE. THE REP REPORTED THAT WHEN THE PHYSICIAN REMOVED THE FORAMEN NEEDLE, THE LEAD ALSO CAME OUT WITH IT; THEY HAVE TWO DAMAGED LEADS. THE LEAD APPEARED TO BE STUCK/HOOKED ONTO THE END OF THE FORAMEN NEEDLE. BOTH THE FORAMEN NEEDLE AND LEAD CAME OUT TOGETHER INSTEAD OF JUST THE FORAMEN NEEDLE AND STYLET BEING REMOVED WITH THE TEMPORARY LEAD REMAINING IN THE PATIENT. THE HEALTHCARE PROVIDER (HCP) ATTEMPTED TO REMOVE THE LEAD FROM THE FORAMEN NEEDLE AND THEN REINSERT THE FORAMEN NEEDLE, BUT THE LEAD APPEARED CURVED/HOOKED AT THE END AND THE COILS WERE STRETCHED. THE REP GOT A NEW LEAD FROM THEIR TRUNK STOCK, THE FORAMEN NEEDLE WAS REINSERTED USING FLUOROSCOPY, AND THE LEAD WAS IMPLANTED WITHOUT ISSUE. NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS CONTRIBUTED TO THE ISSUE. THE PATIENT WAS UNAFFECTED BY THE EVENT; THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. AT THE TIME OF THIS REPORT, THE PATIENT WAS HAVING GREATER THAN 50% IMPROVEMENT FROM THEIR BASELINE SYMPTOMS. NO PATIENT SYMPTOMS WERE REPORTED AND NO FURTHER COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8371737 ↗
• MalfunctionDec 28, 2018Break; Device Damaged Prior to Receipt by User; Break; Device Damaged Prior to Receipt by User

  ADDITIONAL INFORMATION WAS RECEIVED. MANUFACTURER REPRESENTATIVE STATED THAT IT LEAD ISSUE WAS CONSIDER AN OUT OF BOX DAMAGE AND THAT IT WAS RETURNED TO ANALYSIS. NO FURTHER COMPLICATIONS WERE NOTED OR ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8202803 ↗
• InjuryDec 20, 2018Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP), VIA THE MANUFACTURER¿S REPRESENTATIVE, REGARDING A PATIENT WHO UNDERWENT A TRIAL EVALUATION. IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL (HCP) THAT THE TEMPORARY LEAD BROKE DURING ITS REMOVAL IN THE OFFICE AND THEY THOUGHT SOME OF THE LEAD MAY BE UNDERNEATH THE PATIENT¿S SKIN. IT WAS UNKNOWN IF THERE WERE ANY ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED TO THE ISSUE. NO TROUBLESHOOTING WAS PERFORMED EXCEPT FOR TRYING TO REMOVE (UNSUCCESSFULLY) THE LEAD. THE LEAD WAS UNABLE TO BE REMOVED AND THE HCP REPORTED THAT THEY WOULD REMOVE THE LEAD WHEN THE PATIENT HAD THE SURGICAL IMPLANT (DATE OF WHICH HAS NOT BEEN DETERMINED). THE ISSUE WAS NOT RESOLVED AT THE TIME OF REPORT. IT WAS REPORTED THAT THE OFFICE STAFF THREW AWAY THE REMAINING LEADS AND COMPONENTS. THE PATIENT STATUS WAS NOTED AS ¿ALIVE ¿ NO INJURY¿. THERE WERE NO FURTHER COMPLICATIONS REPORTED OR ANTICIPATED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8186077 ↗
• MalfunctionOct 22, 2018Break; Material Perforation; Break; Material Perforation

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN EXTERNAL NEUROSTIMULATOR (ENS). IT WAS REPORTED THAT THE STYLET CAME THROUGH THE LEAD AS THE PHYSICIAN WAS DEPLOYING, CATCHING AND THEN FRAYING THE LEAD. THERE WERE NO KNOWN CONTRIBUTING FACTORS OR TROUBLESHOOTING DONE. A NEW LEAD WAS USED AND REPLACED IN NORMAL FASHION. IT WAS REPORTED THAT THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7989331 ↗
• MalfunctionOct 8, 2018Difficult to Remove; Device Damaged Prior to Receipt by User; Difficult to Remove; Device Damaged Prior to Receipt by User

  INFORMATION WAS RECEIVED BY A TRIAL PATIENT REGARDING AN EXTERNAL NEUROSTIMULATOR (ENS). PATIENT WAS NOT IMPACTED BY THE EVENT. THE PROVIDER WAS PERFORMING THE BASIC EVALUATION (BE) ON THE PATIENT. SHE WENT TO PLACE THE LEAD AND THE STYLET COULD NOT BE REMOVED FROM THE LEAD WITHOUT STRETCHING THE LEAD. THIS OCCURRED WITH 3 LEADS ALL WITH THE SAME LOT NUMBER. SHE WAS FINALLY ABLE TO GET A LEAD WHERE THE STYLET COULD BE REMOVED. PROVIDER TRIED REMOVING THE STYLETS CAREFULLY WITHOUT STRETCHING THE LEAD. SHE TRIED DIFFERENT AMOUNTS OF PRESSURE BUT WAS UNSUCCESSFUL. THE ISSUE WAS RESOLVED AT THE TIME OF THIS REPORT. THE PRODUCTS WERE DISCARDED AND REPLACED. NO SURGICAL INTERVENTION PLANNED OR SCHEDULED. EVENT WAS ALSO REPORTED IN REGULATORY REPORT # 8030670-2018-00006 AND 8030670-2018-00007

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7944200 ↗
• MalfunctionOct 8, 2018Difficult to Remove; Device Damaged Prior to Receipt by User; Difficult to Remove; Device Damaged Prior to Receipt by User

  INFORMATION WAS RECEIVED BY A TRIAL PATIENT REGARDING AN EXTERNAL NEUROSTIMULATOR (ENS). PATIENT WAS NOT IMPACTED BY THE EVENT. THE PROVIDER WAS PERFORMING THE BASIC EVALUATION (BE) ON THE PATIENT. SHE WENT TO PLACE THE LEAD AND THE STYLET COULD NOT BE REMOVED FROM THE LEAD WITHOUT STRETCHING THE LEAD. THIS OCCURRED WITH 3 LEADS ALL WITH THE SAME LOT NUMBER. SHE WAS FINALLY ABLE TO GET A LEAD WHERE THE STYLET COULD BE REMOVED. PROVIDER TRIED REMOVING THE STYLETS CAREFULLY WITHOUT STRETCHING THE LEAD. SHE TRIED DIFFERENT AMOUNTS OF PRESSURE BUT WAS UNSUCCESSFUL. THE ISSUE WAS RESOLVED AT THE TIME OF THIS REPORT. THE PRODUCTS WERE DISCARDED AND REPLACED. NO SURGICAL INTERVENTION PLANNED OR SCHEDULED. EVENT WAS ALSO REPORTED IN REGULATORY REPORT # 8030670-2018-00006.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7944164 ↗
• MalfunctionOct 8, 2018Difficult to Remove; Device Damaged Prior to Receipt by User; Difficult to Remove; Device Damaged Prior to Receipt by User

  INFORMATION WAS RECEIVED BY A TRIAL PATIENT REGARDING AN EXTERNAL NEUROSTIMULATOR (ENS). PATIENT WAS NOT IMPACTED BY THE EVENT. THE PROVIDER WAS PERFORMING THE BASIC EVALUATION (BE) ON THE PATIENT. SHE WENT TO PLACE THE LEAD AND THE STYLET COULD NOT BE REMOVED FROM THE LEAD WITHOUT STRETCHING THE LEAD. THIS OCCURRED WITH 3 LEADS ALL WITH THE SAME LOT NUMBER. SHE WAS FINALLY ABLE TO GET A LEAD WHERE THE STYLET COULD BE REMOVED. PROVIDER TRIED REMOVING THE STYLETS CAREFULLY WITHOUT STRETCHING THE LEAD. SHE TRIED DIFFERENT AMOUNTS OF PRESSURE BUT WAS UNSUCCESSFUL. THE ISSUE WAS RESOLVED AT THE TIME OF THIS REPORT. THE PRODUCTS WERE DISCARDED AND REPLACED. NO SURGICAL INTERVENTION PLANNED OR SCHEDULED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7944134 ↗
• InjuryJul 19, 2018Failure to Advance; Connection Problem; Material Twisted/Bent; Connection Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA MANUFACTURE REPRESENTATIVE (REP) REGARDING A TRIAL PATIENT WITH AN EXTERNAL NEUROSTIMULATOR (ENS). IT WAS REPORTED FOLLOWING THE PLACEMENT AND TESTING OF THE NEEDLE DURING THE PROCEDURE, THE HCP ATTEMPTED TO PLACE THE TEST WIRE INTO THE NEEDLE HUB. THE TEST LEAD WOULD NOT ADVANCE. THE REP STATED UPON INSPECTION IT WAS NOTED THAT THE LEAD WIRE TIP WAS BENT. THE PROBLEM COULD NOT BE CORRECTED BY ADVANCING THE STYLET. THE BENT TIP LEAD WAS REPLACED WITH ANOTHER WIRE. THE REP NOTED THERE WERE NO ENVIRONMENTAL, EXTERNAL, AND PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. IT WAS NOTED THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. THERE WERE NO FURTHER COMPLICATIONS THAT HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7704631 ↗
• MalfunctionJun 21, 2018Difficult to Remove; Device Damaged Prior to Receipt by User; Difficult to Remove; Device Damaged Prior to Receipt by User

  INFORMATION WAS RECEIVED BY A MANUFACTURE REPRESENTATIVE (REP) VIA A HEALTHCARE PROVIDER (HCP) REGARDING A TRIAL LEAD. REP SAID THE HCP WAS IMPLANTING TWO LEADS, BUT THE FIRST ONE GOT STUCK WHEN THEY WENT TO DEPLOY IT. THEY FURTHER SAID THE INNER STYLET OF THE LEAD WOULD NOT COME OUT OF THE ACTUAL LEAD; THEY COULD NOT GET THE STYLET OUT OF THE LEAD ITSELF. AS A RESULT OF WHAT WAS REPORTED, THE LEAD WAS REMOVED AND THE HAD TO PLACE A DIFFERENT ONE. THE REP DID NOT BELIEVE THIS WAS DUE TO PROCEDURAL ISSUES AND SAID THIS WAS AN OUT OF BOX FAILURE. NO PATIENT SYMPTOMS WERE REPORTED AND NO FURTHER COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7626451 ↗
• MalfunctionMay 2, 2018Difficult to Remove; Device Operates Differently Than Expected; Material Deformation; Difficult to Remove; Device Operates Differently Than Expected; Material Deformation

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURE REPRESENTATIVE (REP). IT WAS REPORTED THERE WAS A KINKED LEAD. THE REP STATED THE STYLET IN THE BASIC EVALUATION LEAD WOULD NOT COME OUT OF THE LEAD. THE REP NOTED THERE MAY HAVE BEEN A KINK IN THE STYLET. THE HCP ATTEMPTED TO REMOVED, BUT THEY WERE UNABLE TO. THE REP NOTED THE LEAD WAS REPLACED AND THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. THE REP NOTED WHEN ATTEMPTING TO PLACE THE LEAD DURING A BASIC EVALUATION THE HCP INSERTED THE LEAD AND WHEN HE TRIED TO REMOVE THE STYLET, IT WOULD NOT MOVE. THE HCP TRIED AGAIN AND THE TOP PLASTIC ON THE STYLET POPPED OFF. THE HCP WAS UNABLE TO REMOVE AND REPLACED THE LEAD WITH ANOTHER LEAD THAT HAD THE SAME LOT NUMBER. IT WAS NOTED THE LEAD WOULD BE RETURNED. THERE WERE NO FURTHER COMPLICATIONS THAT HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7481561 ↗
• MalfunctionMar 22, 2018Difficult to Remove; Difficult to Remove

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS BEING IMPLANTED WITH A NEUROSTIMULATOR. IT WAS REPORTED THAT THE LEAD STYLET COULD NOT BE REMOVED. THE LEAD ENDED UP BEING REPLACED WITH A SECOND LEAD, WHICH WORKED, RESOLVING THE ISSUE. THERE WERE NO SYMPTOMS OR FURTHER COMPLICATIONS REPORTED OR ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7361804 ↗
• MalfunctionOct 10, 2017Bent; Break; Bent; Break

  FOLLOW UP INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE REPORTED THAT THE CAUSE OF THE LEAD GETTING STRETCHED WAS UNKNOWN ALTHOUGH THEY MENTIONED IT WAS POSSIBLE THE INNER STYLET WAS KINKED, AND THE LEAD STRETCHED DURING THE PROCESS OF REMOVING THE STYLET. THERE WERE NO FURTHER COMPLICATIONS REPORTED OR ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6933981 ↗
• MalfunctionOct 7, 2017Bent; Bent

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER¿S REPRESENTATIVE REGARDING A PERCUTANEOUS LEAD FOR A TRIAL PRIOR TO IMPLANT. IT WAS REPORTED THAT PRIOR TO DEPLOYING THE TEST LEAD, THE DOCTOR NOTICED THE LEAD WAS BENT AT THE TIP; THEY STILL TRIED TO USE THE LEAD AND WERE UNABLE TO DEPLOY. THERE WAS NO PATIENT INJURY AND THE LEAD WAS NOT USED IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED OR ARE ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6927230 ↗
• MalfunctionOct 2, 2017Bent; Device Damaged Prior to Receipt by User; Bent; Device Damaged Prior to Receipt by User

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A TRIAL PATIENT. IT WAS REPORTED THAT DURING A BASIC EVALUATION PROCEDURE, THE LEAD APPEARED TO BE BENT UPON REMOVAL FROM THE STERILE PACKAGING ONLY AT THE DISTAL EXTERNAL PORTION (~1 CM) FROM END. THIS WAS NOTED AS EITHER A PRODUCT OR PACKAGING ISSUES. THEY PLACED OTHER END IN TROCAR HOWEVER WHEN HEALTHCARE PROFESSIONAL (HCP) WENT TO REMOVE STYLUS, IT WAS STUCK. HCP THEN REMOVED THE LEAD AND REPLACED IT WITH A BRAND NEW LEAD WHICH WENT IN AS EXPECTED WITHOUT ANY ISSUES. PROCEDURE WAS THEN FINISHED WITH ONLY ABOUT 2 MINUTES ADDED TIME. THE TRIAL PROCEEDED WITHOUT ANY ISSUES, AND THERE WERE NO ADVERSE EFFECTS. THE AFFECTED LEAD WAS GOING TO BE RETURNED FOR ANALYSIS. NO SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6907313 ↗
• MalfunctionSep 26, 2017Break; Device Operates Differently Than Expected; Break; Device Operates Differently Than Expected

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE CIRCULATION NURSE PULLED THE LEAD OUT OF THE PROTECTIVE HOOP, AND THE LEAD STYLET BROKE WHICH MADE THE LEAD UNUSABLE. THERE WERE NO ENVIRONMENTAL, EXTERNAL, OR PATIENT FACTORS REPORTED. THE ACCOUNT DISCARDED THE DEFECTIVE LEAD AND OPENED A NEW ONE AND THE ISSUE WAS RESOLVED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6893433 ↗
• MalfunctionJul 25, 2017Break; Difficult to Remove; Connection Problem; Break; Difficult to Remove; Connection Problem

  THE MANUFACTURING REPRESENTATIVE REPORTED THAT IT WAS NOT CERTAIN WHICH LEAD WAS HAVING PROBLEMS. BOTH LEADS WERE OPENED AT THE SAME TIME AND PLACED ON STERILE FIELD BY OFFICE STAFF. DURING THE REMOVAL OF THE NEEDLE, ONE OF THE STYLETS BECAME STUCK INSIDE THE LEAD AND COULD NOT BE REMOVED. SO THEY HAD TO REMOVE THE ENTIRE LEAD WHICH CAUSED THE PATIENT TO BE STUCK AGAIN WITH ANOTHER NEEDLE. THEY REPLACED THE LEAD WITH ANOTHER FROM THE SAME LOT, AND THAT STYLET WAS ALSO DIFFICULT TO REMOVE, BUT THEY WERE ABLE TO REMOVE IT. THE LEAD WAS STRETCHED OUT DURING THE PROCESS OF REMOVING THE STYLET. THE LEAD WAS FUNCTIONAL EVEN THOUGH IT WAS STRETCHED. LEAD HAD TO BE REPLACED AND CAUSED AN UNNECESSARY NEEDLE STICK FOR THE PATIENT. THEY WERE NOT SURE WHICH LEAD WAS THE PROBLEM, SO THAT WAS WHY, THEY INCLUDED BOTH AND RETURNED THE UNUSED PRODUCT PER CUSTOMER REQUEST. PATIENT WAS ADVISED TO CONSULT WITH DOCTOR FOR MORE INFORMATION. THERE WERE NO COMPLICATIONS OR THAT NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6742154 ↗

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