NA 97740 (UDI 00643169518919)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169518919), received between Mar 11, 2019 and Mar 11, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Charging 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 11, 2019Failure to Power Up; Charging Problem; Connection Problem; Insufficient Device Problem Information; Failure to Power Up; Charging Problem; Connection Problem; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED REGARDING A PATIENT IMPLANTED WITH A NEUROSTIMULATOR (INS) USED FOR NON-MALIGNANT PAIN. CONSUMER REPORTED THE DESKTOP CHARGER (DTC) WOULDN'T STAY PLUGGED INTO THE RECHARGER (INSR). IT WAS REPORTED THAT THE CORD WOULD FALL OUT/WAS BROKEN. NO FURTHER COMPLICATIONS REPORTED/ANTICIPATED. 03/08/2019 (B)(4) (REP): ADDITIONAL INFORMATION FROM REPRESENTATIVE WAS RECEIVED. REP STATED PATIENT STILL HAD ISSUES WITH CONNECTOR PIN NOT STAYING IN RECHARGER, AND RECHARGER WOULD NOT TURN ON, PATIENT COULD NOT CHARGE INS TO USE THERAPY FOR NECK. AT FIRST, IT SOUNDED LIKE IT WAS THE SAME ISSUE AS INITIAL CALL. AFTER REVIEWED OF NOTES, REPAIR SAID REPLACEMENT FOR DESKTOP CHARGER WAS NEVER SENT. A REPLACEMENT PATIENT PROGRAMMER WOULD BE SENT. IT WAS MENTIONED DESKTOP CHARGER CONNECTOR PIN WAS BROKEN OFF, AND PP WOULD NOT POWER UP RIGHT. NO FURTHER COMPLICATION AND EVENTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8408224 ↗

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