NA 97740 (UDI 00643169512962)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169512962), received between Mar 30, 2017 and Mar 30, 2017 — classified as 1 malfunction.

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

9 other recalls cover devices cleared under the same FDA submission (P840001); 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 30, 2017Display or Visual Feedback Problem; Battery Problem; Display or Visual Feedback Problem; Battery Problem

  ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT INDICATED THAT THEY NEEDED NEW PROGRAMMER BATTERIES AFTER GETTING MEETING WITH THE MANUFACTURING REPRESENTATIVE (REP) TO CHANGE THEIR PROGRAMS; THEY DIDN¿T REALIZE THE BATTERIES WERE LOW. THE PATIENT NOTED THAT THEY ONLY GOT 2 OF THEIR PROGRAMS BACK AFTER CALLING THE REP. THEY INDICATED THAT IT WAS HARD TO HOLD THE PHONE AND PROGRAMMER AT THE SAME TIME WHEN TALKING WITH THE REP. THEY STATED THEY WILL HAVE TO LEARN TO NAVIGATE DIFFERENTLY WHILE TEMPORARILY USING ONE PROGRAM, UNLESS THEY MEET WITH THE REP AGAIN. THE PATIENT MENTIONED THAT THE ISSUE COULD NOT BE RESOLVED OVER THE PHONE WITH THE REP. THEY NOTED THAT THEY MAY HAVE TO MAKE ARRANGEMENTS TO GET THEIR DEVICE TAKEN OUT SOMEDAY. THE PATIENT INDICATED THEY WEIGHED (B)(6) POUNDS. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6447445 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P840001. 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-1691-2024 · Mar 28, 2024 · Open, Classified
  Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator
• Z-0780-2024 · Dec 19, 2023 · Open, Classified
  Model A710 Intellis Clinician Programmer Application, version 2.0.97
• Z-2159-2021 · Jul 9, 2021 · Open, Classified
  Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290
• Z-1926-2016 · May 3, 2016 · Terminated
  Medtronic RestoreSensor, Model 37714; and, RestoreSensor SureScan, (MRI), Model 97714, Implantable Neurostimulators. Used to treat chronic, intractable pain of the trunk and/or li
• 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-1524-2014 · Feb 27, 2014 · Terminated
  Medtronic neurostimulators. Restore (37711), RestoreADVANCED (37713), RestoreADVANCED SureScan MRI (97713), RestoreSENSOR (37714), RestoreSENSOR SureScan MRI (97714), PrimeAdvanced
• Z-0278-2014 · Sep 30, 2013 · Terminated
  Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable Neurostimulator for Spinal Cord Stimulation.
• Z-1536-06 · Aug 2, 2006 · Terminated
  Medtronic 3777 Lead Kit, 1x8 Low Impedance Lead Kit for Spinal Cord Stimulation (SCS). Manufactured at: Medtronic, Inc., Villalba, Puerto Rico USA. Medtronic, Inc., Minneapolis