Specify® SureScan® MRI 2x8 977C290Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169464667), received between Sep 5, 2017 and Mar 16, 2023 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMar 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MANUFACTURER REPRESENTATIVE RESPONDED STATING THEY HAVE NOT RECEIVED ANY FURTHER INFORMATION IN REGARDS TO THIS PATIENT. ALSO, THEY ADD THEY DO KNOW THAT THERE WERE NO DEVICE ISSUE AS NOTHING WAS IMPLANTED.

  Patient problems: Pain; Paralysis

  MAUDE report 16553684 ↗
• MalfunctionDec 7, 2021Impedance Problem; Impedance Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP). THE CAUSE OF THE CONTACT SHOWING NEGATIVES WAS NOT DETERMINED. TE SWITCHED TO A DIFFERENT LEAD AND THAT LEAD WORKED PERFECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12953013 ↗
• InjuryMar 24, 2021Break; Connection Problem; Break; Connection 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 INTRA-OP AFTER PLACING A SURGICAL LEAD THEY WERE UNABLE TO INSERT THE LEFT LEAD INTO EITHER OF THE HEADER BLOCK OPENINGS. THEY WERE UNABLE TO GET THE FIRST ELECTRODE INTOTHE HEADER BLOCK. THE OTHER LEG OF THE LEAD WENT INTO BOTH HEADER BLOCKS FINE. INITIALLY WHEN ASKED THE LEAD DID NOT LOOK DAMAGED OR DIFFERENT, HOWEVER WHEN THE HEALTHCARE PROVIDER LOOKED CLOSER IT WAS NOTED THE LEAD/DISTAL ELECTRODE APPEARED FLATTER THAN THE OTHER ELECTRODES. THE CALLER STATED NOTHING OCCURRED TO THE LEAD DURING THE PROCEDURE TO CAUSE THE ISSUE. LUBRICATING THE LEAD DID NOT RESOLVE THE ISSUE. THE LEAD WAS REPLACED WITH A DIFFERENT LEAD. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11560767 ↗
• MalfunctionOct 9, 2018Break; Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER'S REPRESENTATIVE REGARDING AN IMPLANTABLE PADDLE LEAD. IT WAS REPORTED THAT THE ELECTRODE ON THE SURGICAL PADDLE THAT WAS GOING TO BE IMPLANTED WAS BENT ON THE PADDLE LEAD. A NEW LEAD WAS GIVEN TO THE HEALTHCARE PROVIDER (HCP) TO CONTINUE WITH IMPLANT. THE ISSUE WAS RESOLVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7949275 ↗
• InjurySep 5, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED VIA A MANUFACTURING REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR (INS). INFORMATION WAS REPORTED THAT DURING A PROCEDURE AS PROVIDER WAS TRYING TO CENTER LEAD IN EPIDURAL CANAL PATIENT LOST NEUROLOGICAL FUNCTION ON RIGHT SIDE OF BODY AS REPORTED BY NEUROMONITORING REPRESENTATIVE. THE SURGEON AND PHYSICIAN ASSISTANT IMMEDIATELY REMOVED THE LEAD AND BEGAN TO FLUSH THE AREA REPEATEDLY. THE PATIENT GAINED FULL MOTION AGAIN, BUT PROVIDER DECIDED TO CANCEL THE CASE AND NOT PROCEED. THE PATIENT HAS A STENT IN HIS BRAIN AND OTHER UNKNOWN ISSUES. NO FURTHER COMPLICATIONS WERE REPORTED. NO ADDITIONAL PATIENT SYMPTOMS WERE REPORTED.

  Patient problems: Neurological Deficit/Dysfunction; Stenosis

  MAUDE report 6841886 ↗

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