Vectris™ SureScan® 977A275 (UDI 00763000006525)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00763000006525), received between Mar 13, 2019 and Jan 30, 2024 — classified as 2 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2024Difficult to Insert; Difficult to Insert

  ON 2021-MAY-27, INFORMATION WAS RECEIVED FROM A MANUFACTURER'S REPRESENTATIVE (REP) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REASON FOR CALL WAS THE MD THOUGHT THAT THE LEAD WAS FAULTY OR THERE WAS A PROBLEM WITH THE NEEDLE BECAUSE THE LEAD WOULDN'T THREAD WELL. THE MD INDICATED THAT THE INSERTION OF THE LEAD IN THE NEEDLE FELT DRY AND ROUGH AND THE LEAD WOULD NOT GLIDE THROUGH THE NEEDLE. THE MD USED A SECOND LEAD WITH NO ISSUE, THE CALLER STATED, THE LEAD IMMEDIATELY WENT IN. TROUBLESHOOTING WAS NOT REQUIRED. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. NO PATIENT SYMPTOMS REPORTED. ON 2021-JUN-03, ADDITIONAL INFORMATION WAS REPORTED THAT THE LEAD WILL BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18606966 ↗
• MalfunctionNov 2, 2022Break; Difficult to Remove; Break; Difficult to Remove

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR PAIN. INFORMATION WAS REPORTED THAT THE STYLET GOT STUCK IN THE NEEDLE AND WHEN IT WAS EVENTUALLY REMOVED IT SEEMED TO COME OUT IN ¿STRINGY¿ PIECES. TROUBLESHOOTING INCLUDED IMPEDANCE CHECK AND MOVING THE LEAD. THE CAUSE WAS NOT KNOWN. THE ISSUE WAS RESOLVED, AND THE LEAD WAS NOT IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15718212 ↗
• MalfunctionMay 6, 2022Break; Difficult to Remove; Break; Difficult to Remove

  A HEALTH CARE PROFESSIONAL REPORTED VIA A MANUFACTURER REPRESENTATIVE (REP) THAT ON (B)(6) 2022, THE LEAD WAS PLACED AND WHEN THE PHYSICIAN WENT TO REMOVE THE GUIDEWIRE, IT WAS STUCK INSIDE THE LEAD AND WOULD NOT COME OUT. THE CAUSE WAS UNKNOWN.  A DIFFERENT LEAD WAS OPENED AND USED, WHICH RESOLVED THE ISSUE. NO SYMPTOMS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14309638 ↗
• MalfunctionMar 24, 2022Break; Material Twisted/Bent; Positioning Problem; Break; Material Twisted/Bent; Positioning Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS UNDERGOING PLACEMENT OF SPINAL CORD STIMULATION LEADS. IT WAS REPORTED THAT THE LEAD GUIDEWIRE BENT DURING THE PROCEDURE, AND THE SURGEON WAS UNABLE TO NAVIGATE AND PLACE THE LEAD UP TO CERVICAL LEVEL. THE PHYSICIAN USED THE SECOND GUIDE WIRE PROVIDED WITH THE LEAD, AND IT WAS BENDING AS WELL. ANOTHER LEAD KIT WAS OPENED AND USED WITH THE SAME RESULT. THE PHYSICIAN WAS UNABLE TO PLACE THE ELECTRODE AT THE CERVICAL LEVEL AND ABORTED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13875086 ↗
• MalfunctionAug 2, 2021Difficult to Insert; Difficult to Insert

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT DURING LEAD PLACEMENT, THE STYLET WAS REMOVED AND REINSERTED. THE STYLET WOULD NOT FULLY ADVANCE DESPITE THE SURGEON¿S CAREFUL HANDLING AND NUMEROUS EFFORTS. ANOTHER LEAD WAS USED AS A RESULT TO RESOLVE THE ISSUE. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12259605 ↗
• MalfunctionJun 8, 2021Break; Difficult to Insert; Break; Difficult to Insert

  THE HEALTH CARE PROFESSIONAL REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE LEAD WAS ATTEMPTED TO BE IMPLANTED. HOWEVER, WHEN THE STYLETS WERE ATTEMPTED TO BE CHANGED OUT, NEITHER (STRAIGHT OR CURVED) WOULD THREAD ALL THE WAY BACK TO THE LEAD TIP. BOTH STYLETS WERE STUCK AT THE 5TH CONTACT. THIS WAS DURING THE PROCEDURE, SO A DIFFERENT LEAD WAS USED AND TWO LEADS WERE ULTIMATELY PLACED. LEAD WAS REMOVED FROM THE BODY TO ATTEMPT TO THREAD THE STYLETS. NEITHER STYLET WOULD THREAD OUTSIDE OF THE BODY EITHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11960967 ↗
• MalfunctionMar 25, 2021Difficult to Insert; Material Twisted/Bent; Difficult to Insert; Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS IMPLAN TED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THE SURGEON TOOK OUT THE ORIGINALLY PLACED BENT STYLET OF LEAD AND ATTEMPTED TO REPLACE IT WITH A NON-BENT STYLET FROM THE LEAD KIT. THEY WERE UNABLE TO INSERT THE STYLET IN THE LEAD. THE SURGEON ATTEMPTED MULTIPLE TIMES AND WERE UNSUCCESSFUL. ANOTHER LEAD WAS OPENED FOR THE SURGEON TO USE AND THE ISSUE WAS RESOLVED. IT WAS NOTED THERE WAS NO PATIENT INVOLVEMENT IN THE EVENT. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11568585 ↗
• MalfunctionMar 22, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A NEUROSTIMULATOR FOR SPINAL CORD STIMULATION (SCS). IT WAS REPORTED THAT A LEAD THAT BELONGED TO THE REPS TRUNK STOCK NOT REGISTERED TO THE PATIENT. CALLER REPORTS AS SHE OPENED THE LEAD, PHYSICIAN NOTICE THE TIP OF THE LEAD, WHERE THE FIRST ELECTRODE, THE TUBING BROKE OFF, ABOUT 1-2 CM. REP REPORTED SHE WILL BE SENDING BACK FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11541625 ↗
• InjuryOct 15, 2020Break; Positioning Problem; Break; Positioning Problem

  INFORMATION WAS REPORTED THAT THE TIP OF THE LEAD FRACTURED WHILE THE PHYSICIAN WAS ADVANCING INTO THE EPIDURAL SPACE. THE LEAD HAD BEEN ADVANCED AND REMOVED SEVERAL TIMES DURING THE PROCEDURE. APPARENTLY THE NEEDLE GOT CAUGHT. A NEW LEAD WAS USED, AND THE ISSUE WAS RESOLVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10683815 ↗
• MalfunctionSep 16, 2020Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE LEAD WOULD RECEIVE THE STYLET AFTER MULTIPLE ATTEMPTS. THERE WERE NO EXTERNAL OR PATIENT FACTORS NOTED TO HAVE CONTRIBUTED TO THE ISSUE. MULTIPLE ATTEMPTS WERE MADE; HOWEVER, THE LEAD WAS REPLACED BY ANOTHER LEAD TO RESOLVE THE ISSUE. IT WAS NOTED THAT THE LEAD THAT WAS REJECTED AND RETURNED WAS "BAD."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10541287 ↗
• MalfunctionNov 4, 2019Impedance Problem; Impedance Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS HAVING A SPINAL CORD STIMULATION SYSTEM IMPLANTED ON THE DAY OF THE REPORT. IT WAS REPORTED THAT THE LEAD WAS IMPLANTED DURING A STANDARD NEW IMPLANT PROCEDURE. WHEN THE LEAD WAS TESTED, AN IMPEDANCE TEST SHOWED THAT CONTACTS 8, 9 , 12, 13, 14, AND 15 ALL HAD A POSSIBLE SHORT/OPEN CONTACT. THE LEAD WAS REMOVED WITHOUT INCIDENT AND REPLACED WITH A NEW LEAD. THERE WERE NO EXTERNAL FACTORS NOTED TO HAVE CAUSED THE ISSUE. REPLACING THE LEAD RESOLVED THE ISSUE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9272062 ↗
• MalfunctionJul 3, 2019Difficult to Remove; Positioning Problem; Difficult to Remove; Positioning Problem

  INFORMATION WAS RECEIVED BY A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURE REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN NON-MALIGNANT PAIN. IT WAS REPORTED THAT THE PATIENT¿S LEAD CONTACTS WERE CATCHING ON THE NEEDLE TIP. THERE WERE NO KNOWN FACTORS THAT CONTRIBUTED TO THE ISSUE. THE HEALTHCARE PROVIDER (HCP) EXCHANGED THE LEAD FOR A DIFFERENT ONE. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. THE LEAD WAS NEVER IMPLANTED AND WOULD BE RETURNED FOR ANALYSIS. THE EVENT OCCURRED ON (B)(6) 2019. ADDITIONAL INFORMATION FROM THE MANUFACTURER REPRESENTATIVE WAS RECEIVED ON 06/18/2019 REPORTING THAT THE HEALTH CARE PROVIDER (HCP) STATED THE LEAD CONTACTS WERE CATCHING ON THE EXIT POINT OF THE TOUHY NEEDLE. THERE WAS POSITIONING DIFFICULTY. THE LEAD WAS REPLACED. THE PATIENT RECOVERED WITHOUT SEQUELA AND THERE WAS NO PATIENT INJURY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8758461 ↗
• InjuryMar 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED BY A MANUFACTURE REPRESENTATIVE (REP) REGARDING A TRIAL PATIENT WITH AN EXTERNAL NEUROSTIMULATOR FOR AN UNKNOWN INDICATION FOR USE. (CERVICAL TRIAL) IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING FEVER, CHILLS, SWEATING AND STATED THAT THE AREA WHERE THE TRIAL LEAD WAS PLACED WAS RED AND SORE. IT WAS UNKNOWN IF THERE WERE ANY CONTRIBUTING FACTORS. IT WAS REPORTED THAT THE PATIENT HAD HAD A SPINAL CORD STIMULATOR (SCS) TRIAL AND A FEW DAYS AFTER THE LEAD PULL, THE PATIENT WAS EXPERIENCING PAIN. THE PATIENT WENT TO THE HOSPITAL AND STATED THAT THEY FOUND AN ABSCESS IN THE EPIDURAL SPACE. IT WAS REPORTED THAT NO ACTIONS WERE TAKEN AT THE TIME OF THE REPORTED AND IT WAS UNKNOWN IF THE ISSUE WAS RESOLVED. THE REP INDICATED THAT THEY HAD NO FURTHER INFORMATION BUT WOULD BE FOLLOWING UP WITH THE HEALTHCARE PROVIDER (HCP) FOR MORE INFORMATION. IT WAS INDICATED THAT THE TRIAL BEGAN ON (B)(6) 2019 AND THE LEAD PULL WAS (B)(6) 2019. THE CUSTOMER DISCARDED THE LEAD SO IT WOULD NOT BE RETURNED FOR ANALYSIS. IT WAS INDICATED THAT THIS WAS A CERVICAL SCS TRIAL. THE INFECTION OCCURRED AFTER THE SCS TRIAL ((B)(6) 2019,POST-OP). NO FURTHER COMPLICATIONS WERE REPORTED/ANTI

  Patient problems: Abscess; Chills; Discomfort; Erythema; Fever; Pain; Sweating; Unspecified Infection

  MAUDE report 8417419 ↗

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