N/A EMBSNV20Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000278267), received between Apr 3, 2023 and Aug 20, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “High impedance” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 20, 2024High impedance; High impedance

  THE MANUFACTURER REPRESENTATIVE (REP) REPORTED THAT ON JUNE 29, 2022 DURING AN ANIMAL STUDY, HIGH IMPEDANCES / OPEN (>40K OHMS) WAS SEEN ON CONTACT 2.  IT WAS NOTED THAT THE IMPLANTED NEUROSTIMULATOR (INS) USED IS A PRE-MARKET DEVICE, BUT THE ADAPTOR-EXTENSION AND THE COMPETITOR LEAD USED WERE POST-MARKET DEVICES.    TROUBLESHOOTING PERFORMED INCLUDED RESEATING THE ADAPTOR IN THE IMPLANTED NEUROSTIMULATOR (INS) WITHIN THE OR, BUT CONTACT 2 CONTINUED TO SHOW UP AS OPEN. AT EXPLANT, CONTACT 2 SHOWED AN OPEN WITH BOTH THE INS AND WITH THE HANDHELD OHMMETER. IT WAS NOTED THAT THE BOOT WAS SUTURED / GLUED WITH MEDICAL ADHESIVE TO THE ADAPTOR AND LEAD TO KEEP FLUID FROM GETTING IN AND AFFECTING THE ECAP MEASUREMENTS, SO THE INVESTIGATOR DID NOT DEFINITIVELY KNOW IF THE ADAPTOR WAS CAUSING THE HIGH IMPEDANCES. FDA CONFIRMED RECEIPT OF NON-MDT PRODUCT NOTIFICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20001870 ↗
• MalfunctionApr 3, 2023High impedance; High impedance

  NO NEW INFORMATION SUBMITTING A CORRECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16667746 ↗

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