NA 3708240 (UDI 00643169272996)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169272996), received between Apr 21, 2017 and Jun 27, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation 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.

• MalfunctionJun 27, 2019Break; Activation, Positioning or Separation Problem; Break; Activation, Positioning or Separation Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) VIA A MANUFACTURER REPRESENTATIVE. IT WAS REPORTED THAT THE EXTENSION CARRIER OF THE EXTENSION STYLET BROKE OFF. IT WAS REPORTED THAT IT WAS EXTREMELY DIFFICULT TO PASS THE TUNNELER IN THE NECK AREA BECAUSE IT WAS VERY TIGHT. THE SURGEON PULLED REALLY HARD AND A PIECE OF THE TUNNELER BROKE OFF AND WAS STUCK IN THE NECK ALONG THE PATH OF THE PASSER. THE SURGEON HAD TO MAKE AN INCISION IN THE NECK TO FIND THE EXTENSION CONNECTOR AND REMOVE THE PIECE OF PLASTIC FROM THE TUNNELER. THE SURGEON THEN RETUNNELED A LITTLE BIT TO GET THE CONNECTOR TO THE CORRECT SPOT. ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). IT WAS CLARIFIED THAT THE PIECE THAT BROKE OFF WAS THE PLASTIC PIECE THAT HOLD THE LAST CARRIER OF THE EXTENSION. THE MANUFACTURER REPRESENTATIVE SUSPECTED THAT THE TUNNELER GOT CAUGHT ON TISSUE ALONG THE TRACK. NO SYMPTOMS OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8739223 ↗
• MalfunctionApr 21, 2017Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE. IT WAS REPORTED THAT THE EXTENSION HAD A DAMAGED SHIPPING BOX AND A DAMAGED PRODUCT BOX PRIOR TO IMPLANT. THE STERILITY OF THE DEVICE WAS QUESTIONABLE. THE EXTENSION WAS NO USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6511487 ↗

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