Vectris™ SureScan® 977A290 (UDI 00763000006549)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000006549), received between Mar 9, 2021 and Oct 14, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 18, 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.

• MalfunctionOct 14, 2021Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A LEAD THAT WAS DEFECTIVE OUT OF BOX. IT WAS REPORTED THAT THE LEAD WAS BEING USED FOR A REVISION, AND WHEN THE PHYSICIAN WENT TO REMOVE THE STYLET, THE ELECTRODES AT THE DISTAL PART WERE BROKEN OFF THE LEAD. THIS WAS ALLEGED TO BE A DEFECTIVE LEAD OUT OF BOX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12632110 ↗
• MalfunctionApr 20, 2021Material Twisted/Bent; Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THERE WAS AN OUT OF BOX FAILURE. IT WAS REPORTED THAT THE STYLET WAS BENT. A NEW LEAD WAS OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11694163 ↗
• MalfunctionMar 9, 2021Positioning Problem; Positioning Problem

  THE MANUFACTURER REPRESENTATIVE REPORTED THAT DURING A TRIAL PROCEDURE THE SECOND LEAD THAT WAS USED STARTED TO COIL AS THERE WAS RESISTANCE AND THE LEAD WOULDN'T ADVANCE ON THE EPIDURAL SPACE DESPITE MULTIPLE ATTEMPTS BY THE PHYSICIAN, SO A 3RD LEAD HAD TO BE OPENED AND USED FOR THE TRIAL.  THE ENTRY LEVEL OF THE LEAD WAS THORACIC VERTEBRA T12 AND LUMBAR VERTEBRA L1 WITH PLACEMENT TO BE AT THE CERVICAL VERTEBRAE.  THE 3RD LEAD WAS ABLE TO BE ADVANCED TO THE CORRECT ANATOMICAL LOCATION SUCCESSFULLY.  NO SYMPTOMS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11446690 ↗

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