NA 37754Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169119215), received between Apr 5, 2018 and Nov 22, 2021 — classified as 1 injury, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 22, 2021Use of Device Problem; Charging Problem; Insufficient Device Problem Information; Use of Device Problem; Charging Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT SOMETIMES THE INS BATTERIES CAUSE INTERFERENCE WITH EACH OTHER DURING INS RECHARGE SESSIONS. THE CALLER EXPLAINED THAT THE INS BATTERIES WERE IMPLANTED IN THE PATIENT'S ABDOMEN AND ARE LOCATED CLOSE TO EACH OTHER. THE CALLER STATED THAT SOMETIMES THE INS RECHARGE SESSION WILL BE "GOOD," BUT SOMETIMES "FUNKY ERROR MESSAGES" APPEAR ON THE RECHARGER RELATED CASE (B)(4). HOWEVER, THE CALLER CONFIRMED THE PATIENT WAS ABLE TO RESOLVE THE ISSUE BY REPOSITIONING THE RECHARGER ANTENNA AND TRYING AGAIN. THE CALLER DID NOT SPECIFY THE ERROR MESSAGES THAT APPEARED ON THE RECHARGER. THE CALLER INDICATED THAT THE PATIENT BECAME USED TO THE INS BATTERIES INTERFERING WITH EACH OTHER DURING INS RECHARGE SESSIONS. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12857180 ↗
• InjuryApr 5, 2018Overheating of Device; Overheating of Device

  INFORMATION WAS RECEIVED FROM A MANUFACTURING REPRESENTATIVE (REP) AND CONSUMER REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR (INS) FOR SPINAL PAIN. INFORMATION WAS REPORTED THAT THE PATIENT HAS EXPERIENCED OVERHEATING OF THEIR RECHARGER. THE PATIENT WAS SLEEPING AND WAS AWOKEN BY HEATING OF THE DERMIS. THE SKIN WAS RED HOWEVER THE REDNESS WAS GONE AFTER SHE AWOKE THE NEXT MORNING. THE PATIENT WAS ASLEEP IN BED AND LYING ON THE CHARGER PADDLE. THE BED COVERS COULD HAVE ADDED TO TRAPPING THE HEAT AT THE CHARGER PADDLE. THE PATIENT CALLED THE REP THURSDAY EVENING (B)(6) 2018 REGARDING THE EVENT. AN APPOINTMENT WAS SCHEDULED WITH THE PATIENT NEXT WEEK TO CHECK HER BATTERY AND CHARGING EQUIPMENT. THE PATIENT WAS ALSO ASKED TO CALL PATIENT SERVICES TO HAVE A LOANER SHIPPED AND RETURN HER DEVICE FOR EVALUATION OR POSSIBLE REPAIR. NO FURTHER COMPLICATIONS WERE REPORTED. NO ADDITIONAL PATIENT SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. THE PATIENT REPORTED THAT THEY RECENTLY GOT BURNED WHILE CHARGING. THE PATIENT CONFIRMED THAT THEY WERE BURNT FROM THEIR RECHARGER ON (B)(6) 2018. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Burning Sensation; Erythema

  MAUDE report 7399899 ↗

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