Vectris™ SureScan® 977A290 (UDI 00643169109377)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00643169109377), received between May 25, 2018 and Jan 11, 2022 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Positioning Problem” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJan 11, 2022Break; Impedance Problem; Break; Impedance Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT PATIENT WAS ON THE SCHEDULE FOR A LEAD REVISION DUE TO POOR IMPEDANCES THE LEFT LEAD ALL ELECTRODES WERE OUT OF RANGE AND NUMBER 12 ON THE RIGHT LEAD. SURGEON MADE INCISION OVER PULSE NEUROSTIMULATOR (PNS) LEAD AND REVEALED THE LEAD SEVERED COMPLETELY IN HALF. PRIOR TO INCISION CONNECTIVITY WAS GOOD EXCEPT FOR ONE ELECTRODE NUMBER 4 WAS RED X¿D. BOTH OLD LEADS WERE TAKEN OUT AND REPLACED WITH NEW ONES. OLD BATTERY STILL REMAINS. NEW CONNECTIVITY AND IMPEDANCE NORMAL. PATIENT DID NOT HAVE ANY FALLS OR ACCIDENTS THAT LEAD TO THIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13225819 ↗
• InjuryJul 23, 2019Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT ONE LEAD WAS CURRENTLY ABANDONED IN THE PATIENT, BUT IT WAS UNKNOWN WHY. THE CAUSE OF THE MIGRATION WAS NOT DETERMINED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8815677 ↗
• InjuryDec 11, 2018Positioning Problem; Positioning Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS GOING TO TRIAL A SPINAL CORD STIMULATION SYSTEM. IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO DO A TRIAL, BUT THE TRIAL WAS ABORTED BECAUSE HE COULD NOT GET THE LEAD INTO THE PROPER LOCATION THAT HE DESIRED. THE PATIENT IS DOING FINE AS OF (B)(6) 2018 AND THERE WERE NO ADVERSE EVENTS REPORTED. A DIFFERENT TRIAL DATE IS SCHEDULED. THERE WERE NO FURTHER COMPLICATIONS REPORTED OR ANTICIPATED. ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT THE HEALTHCARE PROVIDER DISCARDED THE LEADS. NO FURTHER COMPLICATIONS ARE ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8152286 ↗
• InjuryDec 11, 2018Positioning Problem; Positioning Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS GOING TO TRIAL A SPINAL CORD STIMULATION SYSTEM. IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO DO A TRIAL, BUT THE TRIAL WAS ABORTED BECAUSE HE COULD NOT GET THE LEAD INTO THE PROPER LOCATION THAT HE DESIRED. THE PATIENT IS DOING FINE AS OF (B)(6) 2018 AND THERE WERE NO ADVERSE EVENTS REPORTED. A DIFFERENT TRIAL DATE IS SCHEDULED. THERE WERE NO FURTHER COMPLICATIONS REPORTED OR ANTICIPATED. (B)(6) 2018, (REP): ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT THE HEALTHCARE PROVIDER DISCARDED THE LEADS. NO FURTHER COMPLICATIONS ARE ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8152260 ↗
• InjuryDec 11, 2018Positioning Problem; Positioning Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS GOING TO TRIAL A SPINAL CORD STIMULATION SYSTEM. IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO DO A TRIAL, BUT THE TRIAL WAS ABORTED BECAUSE HE COULD NOT GET THE LEAD INTO THE PROPER LOCATION THAT HE DESIRED. THE PATIENT IS DOING FINE AS OF (B)(6) 2018 AND THERE WERE NO ADVERSE EVENTS REPORTED. A DIFFERENT TRIAL DATE IS SCHEDULED. THERE WERE NO FURTHER COMPLICATIONS REPORTED OR ANTICIPATED. (B)(6) 2018. (REP): ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT THE HEALTHCARE PROVIDER DISCARDED THE LEADS. NO FURTHER COMPLICATIONS ARE ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8152228 ↗
• MalfunctionMay 30, 2018Break; Difficult to Insert; Difficult to Remove; Impedance Problem; Break; Difficult to Insert; Difficult to Remove; Impedance Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR UNKNOWN INDICATIONS. IT WAS REPORTED THAT DURING THE IMPLANT SURGERY, THE ELECTRODES WERE GETTING CAUGHT IN THE NEEDLE WHICH PREVENTED THE LEAD FROM BEING ADVANCED OR PULLED BACK THROUGH THE DISTAL TIP OF THE CURVED NEEDLE. THE REP ALSO REPORTED THAT THERE WAS AN OUT OF RANGE IMPEDANCE ON CONTACT 0, EVEN THOUGH ALL IMPEDANCES WERE WITHIN NORMAL LIMITS INTRA-OP AFTER CONNECTING TO THE BATTERY. THERE WERE NO FACTORS IDENTIFIED THAT MIGHT HAVE LED OR CONTRIBUTED TO THE ISSUES AND TROUBLESHOOTING WAS NOT PERFORMED. TO RESOLVE THE ISSUE, IT WAS NOTED THAT THE HCP USED A 3550-14 AND THE ISSUE RESOLVED. THE PATIENT WAS ALIVE WITH NO INJURY. ADDITIONAL INFORMATION RECEIVED FROM THE REP REPORTED THAT THE NEEDLE USED TO INSERT THE LEAD WAS BEING SENT BACK TO THE MANUFACTURE FOR ANALYSIS. THE PATIENT'S INDICATIONS FOR USE WERE REPORTED AS COMPLEX REGIONAL PAIN SYNDROME AND SCIATICA. THE SERIAL NUMBER OF THE INS WAS PROVIDED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7553454 ↗
• MalfunctionMay 25, 2018Difficult to Remove; Device Or Device Fragments Location Unknown; Difficult to Remove; Device Or Device Fragments Location Unknown

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE ON (B)(6) 2018-JUN-01. IT WAS NOTED THAT THE HOSPITAL PROTOCOL WAS TO KEEP THE EXPLANT SO THE LEAD WAS NOT RETURNED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7546034 ↗

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