NA 3095-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994100931), received between Mar 24, 2020 and Mar 24, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Communication or Transmission Problem” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2020Electromagnetic Interference; Failure to Deliver Energy; Failure to Interrogate; Communication or Transmission Problem; Insufficient Device Problem Information; Electromagnetic Interference; Failure to Deliver Energy; Failure to Interrogate; Communication or Transmission Problem; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR (INS) FOR BOWEL DYSFUNCTION/SACRAL NERVE STIM. IT WAS REPORTED THAT THE PATIENT HAD AN MRI AROUND 2 WEEKS AGO AND NOW THEY ARE SEEING A CALL YOUR DOCTOR SCREEN. THE PATIENT COULD NOT RECREATE THE CODE ON THE CALL SO THE LETTERS WERE UNKNOWN. THE PATIENT ALSO STATED THAT THEY THINK THAT IT IS NO LONGER WORKING AS THEY CANNOT COMMUNICATE OR FEEL IT. IT WAS RECOMMENDED THAT THEY FOLLOW UP WITH THEIR HEALTHCARE PROFESSIONAL. NO FURTHER PATIENT COMPLICATIONS ARE ANTICIPATED OR EXPECTED AS A RESULT OF THIS EVENT.

  Patient problems: Therapeutic Effects, Unexpected

  MAUDE report 9871557 ↗

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