NA 3037Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169512955), received between Nov 8, 2016 and Jun 11, 2019 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 11, 2019Inappropriate/Inadequate Shock/Stimulation

  I GOT AN INTERSTIM ICON MODEL 3037 SACRAL NEUROMODULATOR IMPLANTED IN (B)(6) 2016. IT NEVER SEEMED TO HELP WITH MY BLADDER PROBLEMS. IN (B)(6) 2018, IT SHOCKED ME BADLY IN MY SPINE, HIPS, AND DOWN MY RIGHT LEG. LUCKILY MY PARTNER RECOGNIZED WHAT HAD HAPPENED AND FORCEABLY SHUT THE DEVICE DOWN. IT HAS BEEN TURNED OFF SINCE. I'VE ASKED SEVERAL DRS TO SEND A REFERRAL TO UROLOGISTS TO GET THE DEVICE REMOVED, BUT THEY ARE NOT COMFORTABLE ENOUGH TO REMOVE THE DEVICE SINCE THE STUDIES ARE LACKING. THEY CANNOT TAKE OUT THE ANCHORED LEAD WIRE IN MY SACRUM, BUT THEY REMOVE THE WIRES AND BATTERY PACK INSIDE OF MY SKIN. I JUST WANT THE THING TAKEN OUT OF ME SINCE IT'S PERMANENTLY TURNED OFF. IT CONSISTS OF A LEAD WIRE IN MY SACRUM WITH A CORD GOING TO A BATTERY PACK UNDER MY SKIN IN MY BACK. THERE IS AN EXTERNAL PROGRAMMER THAT DOES ELECTRO-SHOCK THERAPY. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Electric Shock

  MAUDE report 8691719 ↗
• InjuryApr 24, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR. THE HCP WAS ENCOUNTERING THE POOR COMMUNICATION SCREEN AND INDICATED THAT IT TOOK 10 MINUTES TO DECREASE FROM 1.8 TO 1.4. THE ISSUE APPEARED TO BE THAT THE PATIENT WAS NOT HOLDING THE PATIENT PROGRAMMER (PP) ON THE SKIN PRESSING THE MINUS BUTTON. THE CALLER INDICATED THAT THE PATIENT WAS IN THE HOSPITAL ABOUT TO HAVE SURGERY, BUT THE TYPE OF SURGERY OR IF THE SURGERY WAS RELATED TO THE PATIENT'S THERAPY WAS NOT REPORTED. PATIENT STATUS IS UNKNOWN AT THE TIME OF THIS REPORT. THERE WERE NO FURTHER COMPLICATION REPORTED OR ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7453690 ↗
• InjuryMar 26, 2018Device Displays Incorrect Message; Communication or Transmission Problem; Device Displays Incorrect Message; Communication or Transmission Problem

  ON (B)(6) 2018 (B)(4) (CON): INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR. PATIENT REPORTED SEEING POOR COMMUNICATION WHEN THEY WENT TO USE THEIR PROGRAMMER TO CHANGE SETTINGS. THE PATIENT PROGRAMMER (PP) WOULD NOT DO TELEMETRY WITH OR WITHOUT ANTENNA. IT WAS NOTED THAT THE PATIENT USED AN ANTENNA. IT WAS REVIEWED FOR PATIENT TO CONFIRM ANTENNA WAS SECURE AND SYNC WITH INS BUT THAT DID NOT RESOLVE THE ISSUE. IT WAS REVIEWED FOR PATIENT TO UNPLUG THE ANTENNA, AND PLACE THE PP DIRECTLY OVER INS, ON SKIN AND SYNC AND THIS DID NOT RESOLVE THE ISSUE EITHER. PATIENT WAS WARM TRANSFERRED TO REPAIR DEPARTMENT. NO PATIENT SYMPTOMS WERE REPORTED. PATIENT'S MEDICAL HISTORY INCLUDED PARKINSON'S DISEASE WHICH WAS THERE PRIOR TO IMPLANT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED/ ANTICIPATED AS A RESULT OF THIS EVENT. ON (B)(6) 2018 (B)(4) (CON): PATIENT REPORTED THE SAME PROGRAMMER ISSUES AND NOTED THAT THE PP WAS REPLACED. PATIENT ALSO REPORTED THE NEED TO GET IN CONTACT WITH THE LOCAL REP BEFORE GETTING DISCHARGED FROM THE HOSPITA

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7371621 ↗
• MalfunctionNov 8, 2016Failure to Power Up; Failure to Power Up

  A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR REPORTED A LOSS OF THERAPY. THE PATIENT STATED THAT THE PATIENT PROGRAMMER (PP) HAS NOT BEEN WORKING/NOT TURNING ON FOR ABOUT ONE WEEK AND THAT ABOUT A WEEK AGO THE PATIENT BEGAN TO HAVE ACCIDENTS AND WANTED TO USE THE PP TO ADJUST THE SETTING. REPLACEMENT OF THE PP BATTERIES RESOLVED THE PP ISSUE AND THE PATIENT STATED THAT SHE WOULD ADJUST HER STIMULATION. TROUBLESHOOTING RESOLVED THE PP ISSUE.

  Patient problems: Incontinence; Therapeutic Response, Decreased

  MAUDE report 6087031 ↗

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