N/A 355028Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169986411), received between Jun 19, 2019 and Feb 20, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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.

• MalfunctionFeb 20, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  INFORMATION WAS RECEIVED FROM AN UNKNOWN SOURCE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). REP REPORTED THEY WERE GIVEN PRODUCT BY AN EMPLOYEE FOR A CASE THE SAME DAY. LEADING UP TO THE CASE, REP DID NOT LOOK AT THE EXPIRATION DATE ON THE PRODUCT THEY WERE GIVEN. THE PRODUCT WAS ONLY NEEDED IF THE CURRENT NEEDLE IN THE LEAD KIT WAS TOO SHORT FOR ACCESS. WHEN THE DOCTOR ASKED REP FOR THE 6 INCH NEEDLES, REP THEN NOTICED THAT THEY EXPIRED IN NOVEMBER 2024. REP MADE THE PHYSICIAN AND STAFF AWARE OF THE EXPIRED PRODUCT. REP GAVE THEM THE OPTION OF A CURVED 6 INCH ACCESS NEEDLE WHICH THEY DECLINED. THE PHYSICIAN INSISTED ON STILL USING THE EXPIRED ACCESS NEEDLES. THEREFORE, THEY USED 2 EXPIRED 355028 DURING THE PROCEDURE. REP NOTED THE ISSUE WAS RESOLVED AND THE NEEDLES WERE DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21421628 ↗
• MalfunctionFeb 20, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ADDITIONAL INFORMATION WAS RECEIVED, IT WAS REPORTED THE NEEDLE IN THE KIT WAS NOT LONG ENOUGH FOR THE PROCEDURE. THE MANUFACTURER REPRESENTATIVE (REP) GAVE THE PHYSICIAN AN ALTERNATIVE TO USE CURVED NEEDLES, HOWEVER THEY REFUSED. THE PHYSICIAN USED THE EXPIRES 6 INCH NEEDLE. THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21421603 ↗
• InjuryJun 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER'S REPRESENTATIVE AND A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE PATIENT HAD A CSF LEAK. A BLOOD PATCH WAS PERFORMED AND THE ISSUE WAS RESOLVED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 8713264 ↗

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