INTERSTIM® 3889-28 (UDI 00643169651111)Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00643169651111), received between Nov 9, 2016 and Oct 23, 2024 — classified as 9 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Break” (16 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 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 23, 2024Break; Difficult to Remove; Break; Difficult to Remove

  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 LEAD FRACTURED, DAMAGED, OR BROKEN DURING REMOVAL. LEAD FRAGMENTED DURING REMOVAL. ATTEMPTED TO REMOVE THE LEAD FROM INSERTION SITE WITH FLURO GUIDANCE. THE CAUSE OF THE ISSUE WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20513972 ↗
• InjuryJul 18, 2023Break; Break

  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 PER CALL TO AXONICS AND SPOKE WITH HEALTHCARE PROVIDER (HCP). CONFIRMED THAT PATIENT URINARY LEAD WAS EXPLANTED DUE TO A FRAGMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17341780 ↗
• InjuryMar 8, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT HEALTHCARE PROFESSIONAL (HCP) FRACTURED LEAD UPON LEAD REMOVAL. PARTIAL EXPLANT DONE. HCP DID DISSECT AND MASSAGE TO REMOVE LEAD BUT LEAD STILL FRACTURED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 13694148 ↗
• MalfunctionSep 2, 2021Break; Break

  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 LEAD WAS REMOVED AT PROPER ANGLE AND BROKE. LEAD FRAGMENT LEFT BEHIND POST REMOVAL. NOT ELIGIBLE FOR MRI. 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 12414341 ↗
• InjuryMay 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP). THEY STATED THEY WOULD DISCUSS THE RESOLUTION OF THE LEAD FRAGMENT WITH RADIOLOGY. THEY ADVISED TO PROCEED WITH MRI VS. SURGICAL EXPLORATION FOR THE ATTEMPTED REMOVAL OF THE GHOST LEAD. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10083276 ↗
• InjuryFeb 19, 2018Failure to Deliver Energy; Unintended Collision; Failure to Deliver Energy; Unintended Collision

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE CAUSE OF THE PATIENT FALL AND NOT FEELING STIMULATION WAS NOT DETERMINED. THERE WERE NO SYMPTOMS OR FURTHER COMPLICATIONS REPORTED OR ANTICIPATED.

  Patient problems: Therapeutic Effects, Unexpected; Therapeutic Response, Decreased

  MAUDE report 7280261 ↗
• MalfunctionNov 1, 2017Break; Device Contamination with Chemical or Other Material; Positioning Problem; Break; Device Contamination with Chemical or Other Material; Positioning Problem

  INFORMATION WAS RECEIVED FROM THE CONSUMER REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR. IT WAS REPORTED THAT IMPLANT PROCEDURE STARTED WITH NO ISSUE. IT WAS NOTED THAT THE PHYSICIAN DID NOT ACHIEVE THE MOST IDEAL PLACEMENT OF THE LEAD AT IMPLANT, SO THEY REMOVED THE LEAD FROM THE INTRODUCER TO ATTEMPT TO RE-INSERT THE LEAD BUT NOTICED WHAT THEY THOUGHT THERE WAS A DEFECT IN THE LEAD WHICH ALLOWED BLOOD TO SEEP INTO THE LEAD. THE PHYSICIAN ATTEMPTED TO CLEAN THE LEAD TO CONFIRM THE BLOOD HAD SEEPED INTO THE INNER WORKINGS OF THE LEAD. IT DID APPEAR THE BLOOD HAD COMPROMISED THE LEAD EVENT AFTER CLEANING IT. THE PHYSICIAN FELT IT BEST TO USE A NEW LEAD FOR THE FEAR THAT IT WOULD CAUSE ISSUES FOR THE PATIENT AND LESSEN THE POSSIBILITY OF SUCCESSFUL THERAPY. NO FACTORS WERE IDENTIFIED THAT MAY HAVE CAUSED THE LEAD DEFECT AS IT WAS NOTED THE PHYSICIAN HAD DONE MANY IMPLANTS WITH THIS DEVICE TYPE WITH NO ISSUES. THE PHYSICIAN DID NOT HANDLE THE LEAD INAPPROPRIATELY OR ATTEMPT ANYTHING OUT OF THE NORM OF THE PROCEDURE. A NEW LEAD WAS THEN USED AND WAS PLACED WITHOUT ISSUE. THE IMPEDANCE CH

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6995079 ↗
• MalfunctionOct 26, 2017Break; Human-Device Interface Problem; Break; Human-Device Interface Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) VIA A HEALTHCARE PROFESSIONAL (HCP) REGARDING A TRIAL PATIENT. IT WAS REPORTED THAT THE INSULATION ON THE LEAD BEGAN TO SHEER AFTER THE PERCUTANEOUS EXTENSION AND BOOT WAS PLACED. THE LEAD WAS EXPOSED. TRIAL PATIENT HAD NO SIDE EFFECTS FROM THIS OCCURRENCE. THE PHYSICIAN DID SAY THERE SEEMED TO BE DIFFICULTY TO SLIDE THE BOOT ALL THE WAY ON. AS SOON AS PHYSICIAN SAW THAT THE EXPOSED WIRE, IT WAS REMOVED AND PLACED WITH A NEW ONE. NO TROUBLESHOOTING WAS DONE. ISSUE WAS RESOLVED AND COMPONENT WILL BE RETURNED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6981105 ↗
• InjuryOct 26, 2017Break; Stretched; Break; Stretched

  INFORMATION WAS RECEIVED BY A MANUFACTURE REPRESENTATIVE (REP) VIA A HEALTHCARE PROVIDER (HCP) REGARDING A LEAD. HCP TRIED TO PUT THE LEAD DOWN INTRODUCED AND WHEN THEY PULLED IT BACK OUT, THE LEAD STRETCHED AND THEY BROKE THE LEAD AD THE TIP. IT WAS REPLACED AND A NEW LEAD WAS IMPLANTED. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. NO PATIENT SYMPTOMS AND NO FURTHER COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6979355 ↗
• InjuryOct 16, 2017Break; Connection Problem; Break; Connection Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT THE CAUSE OF THE LEAD DAMAGE WAS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6952454 ↗
• MalfunctionOct 6, 2017Break; Peeled/Delaminated; Break; Peeled/Delaminated

  THE PATIENT REPORTED THAT THE PROTECTIVE COVERING CAME OFF THE LEAD WHEN DOCTOR WAS PULLING THE BOOT OVER THE EXTENSION DURING THE STAGE 1. NO TROUBLESHOOTING WAS PERFORMED. THE LEAD WAS VISIBLE BROKEN. WE HAD TO PLACE ANOTHER LEAD. THE WAS NO SURGICAL OR INTERVENTION PLANNED OR OCCURRED. THE ISSUE WAS RESOLVED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6919504 ↗
• MalfunctionAug 11, 2017Difficult to Insert; Difficult to Remove; Difficult to Insert; Difficult to Remove

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE. IT WAS REPORTED THAT THE LEAD HAD DIFFICULTY PASSING AND WITHDRAWING AND THE LEAD WAS NOT PLACED PAST THE COLLAR AT ANY TIME AND NEVER IMPLANTED. NO SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6787706 ↗
• MalfunctionAug 4, 2017Connection Problem; Material Deformation; Connection Problem; Material Deformation

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER¿S REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTED NEUROSTIMULATOR (INS) FOR GASTROINTESTINAL /PELVIC FLOOR THERAPY. IT WAS REPORTED THAT THE LEAD WOULD NOT PULL OUT WITH PULL PRESSURE FROM THE PERCUTANEOUS EXTENSION. UPON INSPECTION, IT APPEARED THE ZERO ELECTRODE WAS BENT WHICH COULD HAVE EXPLAINED DIFFICULTY IN REMOVING LEAD FROM EXTENSION PER THE PHYSICIAN. IT WAS STATED MAYBE THE LEAD WAS PUSHED TOO FAR IN WHEN STAGE 1 (TRIAL) WAS DONE. THE ISSUE WAS RESOLVED AND THE LEAD REMAINED IMPLANTED. NO SYMPTOMS WERE REPORTED, PATIENT WAS ALIVE WITH NO INJURY AND NO FURTHER COMPLICATIONS WERE REPORTED OR ARE ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6769134 ↗
• InjuryJun 27, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A CONSUMER (CON) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT UNDERGOING A STAGE 1 EVALUATION. IT WAS REPORTED THAT, AFTER THE STAGE 1 LEAD IMPLANT, THE PATIENT COMPLAINED OF LEG PAIN. THE PATIENT WAS INSTRUCTED TO TURN STIMULATION DOWN AND TO NEVER INCREASE STIMULATION TO A LEVEL OF DISCOMFORT. THE PATIENT FOLLOWED UP WITH THEIR DOCTOR AND WAS INSTRUCTED TO LEAVE THE DEVICE OFF FOR 4 DAYS TO SEE IF THE LEG PAIN RESOLVED, AND TO TAKE ALEVE MEDICATION. ON 2017-06-19, IT WAS REPORTED BY A REP THAT THE LEAD WAS REMOVED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: Pain

  MAUDE report 6669578 ↗
• MalfunctionJun 21, 2017Break; Failure to Deliver Energy; Break; Failure to Deliver Energy

  INFORMATION WAS RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE PATIENT FELT NOTHING ON THE LEAD DURING TESTING AND THE LEAD LOOKED LIKE IT WAS DAMAGED. THERE WERE NO ENVIRONMENTAL, EXTERNAL, OR PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. THIS LEAD WAS NOT USED AND A NEW LEAD WAS USED WITH THE ISSUE BRING RESOLVED. NO PATIENT SYMPTOMS WERE REPORTED. 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; Therapeutic Effects, Unexpected

  MAUDE report 6658350 ↗
• MalfunctionJun 1, 2017Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS BEING IMPLANTED WITH A NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE LEAD WAS PLACED, AND DID NOT WORK, IT WAS DAMAGED; NO SENSATION WAS FELT BY THE PATIENT. IT WAS NOTED THAT WHEN A NEW LEAD WAS USED, THE ISSUE WAS RESOLVED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6604863 ↗
• MalfunctionMay 17, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE MANUFACTURING REPRESENTATIVE REPORTED FROM DOCUMENT THAT LEADS DID NOT WORK. NO OTHER INFORMATION WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6572701 ↗
• MalfunctionMay 12, 2017Device Operates Differently Than Expected; Insufficient Device Problem Information; Device Operates Differently Than Expected; Insufficient Device Problem Information

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE (REP) THAT THE TORQUE WRENCH DID NOT CLICK WHEN THE SCREW WAS TIGHTENED DOWN THE EXTENSION. THE REP NOTED IT JUST CONTINUED TO ROTATE WITH NO AUDIBLE SOUND. THERE WERE NO ENVIRONMENTAL, EXTERNAL, OR PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. THE REP NOTED THE HCP CONTINUED TO TRY THE SCREWDRIVER ON OTHER SET SCREWS ON THE EXTENSION. THE HCP BACKED OUT OF THE SCREWS, A NEW TORQUE WRENCH WAS PROVIDED AND THAT WRENCH MADE THE AUDIBLE CLICK. 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. THE PATIENT IS IMPLANTED FOR GASTROINTESTINAL/PELVIC FLOOR.

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

  MAUDE report 6562743 ↗
• InjuryMay 12, 2017High impedance; High impedance

  INFORMATION WAS RECEIVED BY A MANUFACTURE REPRESENTATIVE (REP) VIA A HEALTHCARE PROVIDER (HCP) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR. WHILE INTRA-OP, A LEAD WAS IMPLANTED DURING A STAGE 2 IMPLANT. DURING INTRA-OP TESTING, IMPEDANCE TESTING WAS GREATER THAN 4000 OHMS ON ALL COMBINATIONS EXCEPT FOR 1. AMPLITUDE WAS ADJUSTED TWICE TO 1.5V THEN 2.0V AS WELL AS A PULSE WIDTH TO 270 WHICH STILL IMPEDED OUT. THE HCP DECIDED TO REMOVE AND REPLACE THE LEAD. THE LEAD WILL BE RETURNED TO BE ANALYZED. NO PATIENT SYMPTOMS AND NO FURTHER COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6562677 ↗
• MalfunctionApr 12, 2017Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) AND A MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT THE PLASTIC CASING OF THE LEAD CAME SLIGHTLY UNDONE AND EXPOSED THE WIRE OF THE LEAD BELOW THE ELECTRODES. THE LEAD WAS TESTED AND IT STILL WORKED. IT WAS NOTED THAT THE WIRE WAS COVERED UP WHEN THE PERCUTANEOUS EXTENSION WAS PLACED. THE HCP TESTED EACH ELECTRODE AND THE PATIENT WAS STILL GETTING A MOTOR RESPONSE. THE PATIENT WAS BEING TESTED DURING AN ADVANCED EVALUATION AND FELT THE APPROPRIATE STIMULATION VAGINALLY. IT WAS INDICATED THAT IT WAS UNKNOWN IF THERE WERE ANY ENVIRONMENTAL, EXTERNAL, OR PATIENT FACTORS THAT MAY HAVE LED TO THE ISSUE. THE REP NOTED THAT THEY PROCEEDED WITH THE TRIAL AND INDICATED THAT THE PATIENT WAS STAGE 1. THE REP REPORTED THAT STAGE 1 WAS GOING WELL AT THE TIME OF REPORT AND ASKED IF THE LEAD SHOULD BE REVISED IF THE PATIENT GOES TO FULL IMPLANT. THE REP WAS REVIEWED THAT IT WOULD BE A MEDICAL DECISION. IT WAS ADVISED THAT EVEN IF THE COMPROMISED PART IS INSIDE THE HEADER BLOCK IT MAY BE BEST TO REVISE THE LEAD AS THE LEAD WOULD BE MORE SUSCEPTIBLE TO ISSUES IN THE FUTURE IF IT'S ALREADY COMPROMISED. NO FURTHER COMPLICATIONS W

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6486750 ↗
• MalfunctionMar 31, 2017High impedance; Device Contaminated During Manufacture or Shipping; High impedance; Device Contaminated During Manufacture or Shipping

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS BEING IMPLANTED WITH A NEUROSTIMULATOR. DURING THE PROCEDURE, A SMALL AMOUNT OF FLUID WAS VISIBLE INSIDE THE LEAD TIP. AN IMPEDANCE CHECK SHOWED HIGH IMPEDANCES ON COMBINATIONS INVOLVING ELECTRODE 2. HOWEVER, THE PHYSICIAN DECIDED TO NOT REPLACE THE LEAD DUE TO THE PATIENT'S AGE. THE PATIENT TESTED SUCCESSFULLY ON PROGRAM 0-, 1-, AND 3+, SO THE ELECTRODES WITH THE HIGH IMPEDANCES WERE NOT UTILIZED. THE PHYSICIAN NOTED THAT THEY WOULD REVISE THE LEAD AT A LATER DATE IF THE PATIENT DIDN'T HAVE EFFICACY. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. THERE WERE NO SYMPTOMS OR FURTHER COMPLICATIONS REPORTED OR ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6449450 ↗
• InjuryMar 24, 2017Break; Break

  A COMPANY REPRESENTATIVE REPORTED THAT DURING THE PROCEDURE, THE LEAD BROKE BETWEEN 1 AND 2 WHERE THE LEAD GOES INTO THE HEADER BLOCK. IT WAS NOTED THAT THE LEAD MUST HAVE BEEN DEFECTIVE AND VISIBLY BROKEN. THEY REPLACED LEAD WITH ANOTHER LEAD AND ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. PATIENT STATUS WAS NOTED AS ALIVE, NO INJURY. 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 6431625 ↗
• MalfunctionMar 16, 2017Break; Break

  NO NEW INFORMATION RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6409616 ↗
• MalfunctionFeb 18, 2017Break; Break

  THE LEAD WAS RETURNED FOR ANALYSIS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6342311 ↗
• MalfunctionNov 15, 2016Peeled/Delaminated; Human-Device Interface Problem; Peeled/Delaminated; Human-Device Interface Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A TRIAL PATIENT. IT WAS REPORTED THAT THE LEAD INSULATION AT THE PROXIMAL END PULLED AWAY FROM THE CONTACTS EXPOSING THE 4 WIRES INSULATED WIRES IN THE LEAD. THE REP FURTHER STATED THAT THE DOCTOR PLACED THE LEAD, CONNECTED THE LEAD TO THE EXTENSION. AFTER SUTURING THE BOOT AROUND THE LEAD/EXTENSION THE INSULATION PULLED OFF OF THE LEAD. IT WAS ALSO INDICATED THAT THERE WAS NO INJURY TO THE PATIENT AS A RESULT OF THE LEAD PROBLEM. THE LEAD WAS REPLACED WITH A NEW LEAD WITHOUT ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6104254 ↗

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-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
• 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