NA 3708140Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169887749), received between May 6, 2024 and Jan 2, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Receipt by User” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 2, 2025Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS). THE REASON FOR THE CALL WAS THE CALLER STATED THEY WERE IN A CASE FOR A BURIED LEAD TRIAL USING 37081 EXTENSIONS. THE CALLER STATED THAT THE HCP ATTEMPTED TO USE THE CONNECTOR BOOT BUT HAD A HARD TIME PUTTING IT ON AND FELT THAT IT WAS "STRETCHING THE EXTENSION". THEREFORE, THE HCP ELECTED TO NOT USE THE BOOT, AND THE CALLER INQUIRED ABOUT IRRIGATING THE CONNECTION. TROUBLESHOOTING WAS NOT REQUIRED. THE TROUBLESHOOTING STEPS THAT WERE TAKEN ON THE CALL RESOLVED THE ISSUE. THE TECHNICAL SERVICES SPECIALIST (TSS) REVIEWED INFORMATION FOR THE MANUAL ABOUT PLACING THE BOOT AND IRRIGATION. TSS REVIEWED THAT WITHOUT THE BOOT, THE CONNECTION MAY BE MORE LIKELY TO HAVE FLUID INGRESS, BUT IT IS THE HCP'S DECISION AROUND IRRIGATING THE CONNECTION. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21056778 ↗
• MalfunctionJul 17, 2024Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A TRIAL EXTENSION. THE REP REPORTED WHILE OPENING AN EXTENSION TO BE USED DURING A TRIAL, THE PLASTIC PACKAGING BROKE RATHER THAN THE PAPER COVERING COMING OFF. THE DEVICE WAS NEVER IMPLANTED AND WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19766705 ↗
• MalfunctionMay 6, 2024Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  A DISTRIBUTOR REPORTED THAT ¿THE EXTENSION PACKAGING WAS FOUND TO BE DAMAGED DURING THE OPERATION¿ AND THAT ¿THE INTERNAL PACKAGING BOX WAS DAMAGED AFTER OPENING.¿ IT WAS ASKED, BUT UNKNOWN WHETHER ANY DAMAGE WAS OBSERVED ON THE DEVICE¿S EXTERNAL PACKAGING. IT WAS STATED THAT THE NEW EXTENSION WAS REPLACED ON THE SAME DAY IN ORDER TO COMPLETE THE OPERATION; THE ISSUE WAS RESOLVED AT THE TIME OF REPORT. THE CAUSE OF THE PACKAGING DAMAGE WAS UNKNOWN. THERE WERE NO SURGICAL INTERVENTIONS PLANNED OR PERFORMED AND THE PATIENT WAS ALIVE WITH NO INJURY AT THE TIME OF REPORT. NO COMPLICATIONS WERE REPORTED OR ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19249327 ↗

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