NA 3550-43Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994190031), received between Nov 6, 2018 and Aug 22, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Positioning Problem” (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.

• MalfunctionAug 22, 2024Adverse Event Without Identified Device or Use Problem; Positioning Problem; Adverse Event Without Identified Device or Use Problem; Positioning Problem

  PREVIOUSLY SYSTEM REPORTED IN REPORT NUMBER: 2649622-2018-10719.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20041981 ↗
• MalfunctionMay 29, 2019Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE PROFESSIONAL (HCP) REPORTED VIA THE MANUFACTURER REPRESENTATIVE THAT THE LEAD GOT STUCK IN THE NEEDLE. THE HCP HAD MADE NUMEROUS ATTEMPTS TO PLACE THE LEAD PRIOR TO IT GETTING STUCK. WHEN THE HCP PULLED THE NEEDLE OUT ALONG WITH THE LEAD THEY HAD TO PULL THE LEAD OUT FORCEFULLY. THE HCP DECIDED TO USE ANOTHER LEAD AND NEEDLE JUST IN CASE THE LEAD WAS DAMAGED. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. NO PATIENT SYMPTOMS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 8650886 ↗
• MalfunctionNov 6, 2018Positioning Problem; Positioning Problem

  INFORMATION WAS RECEIVED FROM A HEALTH CARE PROFESSIONAL (HCP) VIA A MANUFACTURING REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTABLE NEURO STIMULATOR (INS). DURING THE INTRA OPERATIVE PERIOD OF THE TRIAL IT WAS REPORTED THAT PHYSICIAN ATTEMPTED TO PLACE LEAD THROUGH THE NEEDLE AND WHEN HE ATTEMPTED TO PULL THE LEAD THROUGH THE NEEDLE TO REPOSITION THE NEEDLE THE LEAD CONTACT BECAME LODGED AT THE TIP OF THE NEEDLE SO THE HCP HAD TO PULL BOTH THE NEEDLE AND LEAD OUT TOGETHER AND START OVER WITH A DIFFERENT NEEDLE AND LEAD. PHYSICIAN PULLED THE AFFECTED LEAD AND NEEDLE OUT TOGETHER AND STARTED OVER WITH A NEW NEEDLE AND NEW LEAD. THE ISSUE WAS RESOLVED AT THE TIME OF THIS REPORT. LEAD NEVER IMPLANTED. NO SURGICAL INTERVENTION OCCURRED OR PLANNED. PATIENT IS ALIVE WITH NO INJURY. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER'S REPRESENTATIVE. IT WAS REPORTED THAT THE CAUSE OF THE LEAD CONTACT BECOMING LODGED IN THE TIP OF THE NEEDLE WAS NOT DETERMINED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 8043346 ↗

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