Vectris™ 977D260 (UDI 00643169118249)Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 00643169118249), received between Feb 15, 2017 and Jul 25, 2018 — classified as 5 injuries, 38 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Receipt by User” (27 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 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 25, 2018High impedance; Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED BY A MANUFACTURE REPRESENTATIVE (REP) VIA A HEALTHCARE PROFESSIONAL (HCP) REGARDING A PATIENT WITH AN EXTERNAL NEUROSTIMULATOR (ENS). THERE WAS A LEAD ISSUE DURING THE PROCEDURE. THERE WERE HIGH IMPEDANCES ON ELECTRODES 4, 5, 6, AND 7. THE LEAD WAS NOT WORKING ON ELECTRODES 4-7 NO MATTER WHAT THEY DID. THEY READJUSTED THE LEAD IN THE ENS, READJUSTED THE LEAD INTO A DIFFERENT ENS PORT, REMOVED AND CLEANED OFF THE LEAD, AND REPOSITIONED THE LEAD. THEY EVENTUALLY REPLACED THE LEAD WITH A NEW ONE WHICH RESOLVED THE ISSUE. THERE WERE NO ISSUES WITH THE NEW LEAD. THERE WERE NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. THE LEAD WAS NEVER IMPLANTED AND WOULD BE RETURNED FOR ANALYSIS. THE PATIENT WAS NOTED TO BE ALIVE WITH NO INJURY. THERE WERE NO PATIENT SYMPTOMS REPORTED AND NO COMPLICATIONS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7718710 ↗
• MalfunctionJul 12, 2018Break; Material Twisted/Bent; Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A TRIAL PATIENT BEING IMPLANTED WITH AN UNKNOWN SPINAL CORD STIMULATOR MODEL. IT WAS REPORTED THAT ON (B)(6) 2018 DURING A TRIAL LEAD IMPLANT PROCEDURE, THE TRIAL LEAD WAS DAMAGED; AN ELECTRODE LOOKED LIKE IT HAD BROKEN OFF OF THE LEAD WHEN THE DOCTOR WAS DEPLOYING THE LEAD FROM THE NEEDLE/INTRODUCER. THE DOCTOR DECIDED TO USE ANOTHER LEAD. NO SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7683116 ↗
• InjuryJul 9, 2018Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURE REPRESENTATIVE REGARDING A TRIAL PATIENT WITH AN EXTERNAL NEUROSTIMULATOR (ENS). IT WAS REPORTED THAT DURING PLACEMENT OF THE SECOND TRIAL LEAD THE PHYSICIAN DID A 'WET TAP' AND THE SECOND LEAD WAS REMOVED. A BLOOD PATCH WAS PERFORMED AT THE TIME OF THE LEAD PULL FOR THE CEREBRAL SPINAL FLUID (CSF) LEAK, AND THE PATIENT LAID FLAT FOR AN EXTENDED PERIOD OF TIME IN RECOVERY AFTER THE LEAD PULL. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 7669318 ↗
• MalfunctionJun 3, 2018Bent; Bent

  INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) VIA THE MANUFACTURER¿S REPRESENTATIVE REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE STYLET OF THE STRAIGHT NEEDLE WAS BENT. THERE WERE NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED TO THE ISSUE. NO ACTIONS/INTERVENTIONS WERE TAKEN FOR THE ISSUE. THE ISSUE WAS REPORTED AS RESOLVED AT THE TIME OF THE REPORT. NO SURGICAL INTERVENTION HAD OCCURRED AND NONE WERE PLANNED. THE PATIENT STATUS WAS NOTED AS ¿ALIVE ¿ NO INJURY¿. FOLLOW UP INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE ON JUNE 1, 2018 REPORTED THE BENT STYLET WAS USED IN THE PATIENT. SPECIFICALLY, THE PHYSICIAN PLACED THE TOUHY NEEDLE AS USUAL AND, WHEN THEY PULLED IT OUT, THE STYLET WAS MINIMALLY BENT. THE CAUSE OF THE ISSUE WAS NOT DETERMINED. THERE WERE NO FURTHER COMPLICATIONS REPORTED OR ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7564112 ↗
• MalfunctionMay 30, 2018Difficult to Remove; Difficult to Remove

  THE HEALTHCARE PROFESSIONAL (HCP) REPORTED VIA THE MANUFACTURER REPRESENTATIVE THAT WHILE PLACING THE LEAD IN THE EPIDURAL SPACE THEY COULDN¿T PULL THE LEAD BACK AS IT GOT STUCK IN THE NEEDLE. THE HCP PULLED OUT THE NEEDLE AND LEAD AND WAS ABLE TO PULL THE LEAD OUT OF THE NEEDLE FROM THE DISTAL END OF THE NEEDLE. THE HCP THEN PLACED THE LEAD IN ANOTHER NEEDLE AND THAT WORKED FINE. IT WAS NOTED THAT IT WAS THE CURVED NEEDLE IN THE KIT THAT WOULD NOT ALLOW THEM TO PULL THE LEAD BACK OUT OF THE NEEDLE PROPERLY. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. NO PATIENT SYMPTOMS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7555351 ↗
• MalfunctionMay 30, 2018Break; Difficult to Remove; Device Damaged Prior to Receipt by User; Device Operates Differently Than Expected; Break; Difficult to Remove; Device Damaged Prior to Receipt by User; Device Operates Differently Than Expected

  MANUFACTURER REPRESENTATIVE REPORTED AND OUT OF BOX FAILURE. IT WAS REPORTED THAT HEALTHCARE PROVIDER (HCP)COMPLAINED THE CURVED TIP NEEDLES PROVIDED IN LEADS KITS WERE POOR QUALITY. WHEN INSERTING THE LEAD INTO THE NEEDLE, IT IS NOT MOVING SMOOTHLY THROUGH THE HUB AND ONCE THE ELECTRODES EXIT THE NEEDLES, IT IS EXTREMELY DIFFICULT TO RETRACT THE LEAD BACK INTO THE NEEDLE. THERE WAS SOME TYPE OF PARTIAL OCCLUSION OR BURR OR SOMETHING LIKE THAT. HE ALSO ADDED THAT WHEN AN ELECTRODE IS OUTSIDE OF THE NEEDLE TIP, IT IS DIFFICULT TO RETRACT AND HE HAS TO REDO THE EPIDURAL. THE HCP COMMENTED "THESE NEEDLES ARE TERRIBLE." NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED. ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE. IT WAS REPORTED THE EVENT OCCURRED DURING A TRIAL. THE AFFECTED DEVICES WERE GOING TO BE RETURNED FOR ANALYSIS. NO FURTHER COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED FROM A REPRESENTATIVE (REP) AND A HEALTHCARE PROFESSIONAL (HCP) REGARDING THE PATIENT. IT WAS REPORTED THAT THE ELECTRODES WERE NOT PASSING SMOOTHLY THROUGH THE TIP OPENING OF THE NEEDLE. THE REP STATED THAT THERE WAS A SLIGHT EX

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7554397 ↗
• MalfunctionMay 30, 2018Break; Difficult to Remove; Device Damaged Prior to Receipt by User; Device Operates Differently Than Expected; Insufficient Device Problem Information; Break; Difficult to Remove; Device Damaged Prior to Receipt by User; Device Operates Differently Than Expected; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE CONCERNING A TRIAL PATIENT. AN OUT OF BOX FAILURE WAS REPORTED. IT WAS REPORTED THAT HEALTHCARE PROVIDER (HCP) COMPLAINED THE CURVED TIP NEEDLES PROVIDED IN LEADS KITS WERE POOR QUALITY. WHEN INSERTING THE LEAD INTO THE NEEDLE, IT IS NOT MOVING SMOOTHLY THROUGH THE HUB AND ONCE THE ELECTRODES EXIT THE NEEDLES, IT IS EXTREMELY DIFFICULT TO RETRACT THE LEAD BACK INTO THE NEEDLE. THERE WAS SOME TYPE OF PARTIAL OCCLUSION OR BURR OR SOMETHING LIKE THAT. HE ALSO ADDED THAT WHEN AN ELECTRODE IS OUTSIDE OF THE NEEDLE TIP, IT IS DIFFICULT TO RETRACT AND HE HAS TO REDO THE EPIDURAL. THE HCP DEMONSTRATED IT TODAY FOR THE REPRESENTATIVE AND SHE OBSERVED IT AS WELL. THE HCP COMMENTED "THESE NEEDLES ARE TERRIBLE." NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7554221 ↗
• MalfunctionMay 30, 2018Break; Difficult to Remove; Device Damaged Prior to Receipt by User; Device Operates Differently Than Expected; Insufficient Device Problem Information; Break; Difficult to Remove; Device Damaged Prior to Receipt by User; Device Operates Differently Than Expected; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE CONCERNING A TRIAL PATIENT. AN OUT OF BOX FAILURE WAS REPORTED. IT WAS REPORTED THAT HEALTHCARE PROVIDER (HCP) COMPLAINED THE CURVED TIP NEEDLES PROVIDED IN LEADS KITS WERE POOR QUALITY. WHEN INSERTING THE LEAD INTO THE NEEDLE, IT IS NOT MOVING SMOOTHLY THROUGH THE HUB AND ONCE THE ELECTRODES EXIT THE NEEDLES, IT IS EXTREMELY DIFFICULT TO RETRACT THE LEAD BACK INTO THE NEEDLE. THERE WAS SOME TYPE OF PARTIAL OCCLUSION OR BURR OR SOMETHING LIKE THAT. HE ALSO ADDED THAT WHEN AN ELECTRODE IS OUTSIDE OF THE NEEDLE TIP, IT IS DIFFICULT TO RETRACT AND HE HAS TO REDO THE EPIDURAL. THE HCP DEMONSTRATED IT TODAY FOR THE REPRESENTATIVE AND SHE OBSERVED IT AS WELL. THE HCP COMMENTED "THESE NEEDLES ARE TERRIBLE." NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7554186 ↗
• MalfunctionMay 30, 2018Difficult to Insert; Difficult to Remove; Difficult to Insert; Difficult to Remove

  INFORMATION WAS RECEIVED FROM A MANUFACTURING REPRESENTATIVE (REP) REGARDING A TRIAL PATIENT. INFORMATION WAS REPORTED THAT A PHYSICIAN INSERTED CURVED TIP NEEDLE, TRIED TO ADVANCE THEN WHEN THEY TRIED TO PULL THE LEAD BACK OUT OF THE NEEDLE IT WOULDN'T COME BACK OUT, SO THEY HAD TO WITHDRAW THE NEEDLE COMPLETELY. THE CALLER STATED THEY TRIED ANOTHER CURVED TIP NEEDLE WITH THE SAME ISSUE, ALMOST AS IF THE ELECTRODES WERE CATCHING ON THE EDGE OF THE NEEDLE, SO IT WOULDN'T GO IN AND OUT EASILY. THE CALLER STATED THEY USED ANOTHER LEAD THAT WORKED FINE. NO FURTHER COMPLICATIONS WERE REPORTED. NO PATIENT SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE. IT WAS REPORTED THAT THE PHYSICIAN COULD NOT ADVANCE OR WITHDRAW THE LEAD THROUGH THE NEEDLE WITHOUT IT HANGING UP ON ELECTRODE CONTACTS. IT WAS NOTED THAT THE CAUSE OF THIS ISSUE WAS NOT DETERMINED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7553664 ↗
• MalfunctionMay 30, 2018Difficult to Remove; Difficult to Remove

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE. IT WAS REPORTED THAT THE SURGEON PASSED THE LEAD THROUGH THE END OF THE INCLUDED CURVED TIP NEEDLE. IN THE COURSE OF PLACING THE LEAD, THE SURGEON ATTEMPTED TO SLIGHTLY WITHDRAW THE LEAD AND IT GOT STUCK IN THE TIP OF THE NEEDLE. THE SURGEON HAD TO REMOVE THE NEEDLE AND FORCEFULLY FREE THE LEAD FROM NEEDLE. ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURE REPRESENTATIVE (REP) ON (B)(6) 2017. THE REP STATED THAT THE CAUSE REMAINS UNKNOWN, SO THE ITEM WOULD BE RETURNED ON 2017-NOV-20. THE LEAD, STYLET, AND EPIDURAL NEEDLE WERE RECEIVED FOR ANALYSIS ON (B)(6) 2017. THERE WERE NO PATIENT SYMPTOMS REPORTED AND NO COMPLICATIONS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7552735 ↗
• MalfunctionMay 30, 2018Difficult to Insert; Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Difficult to Insert; Difficult to Remove; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS BEING IMPLANTED WITH A NEUROSTIMULATOR (INS). IT WAS REPORTED THAT INTRA-OP, THE PHYSICIAN WAS UNABLE TO PULL THE LEAD OUT THROUGH THE NEEDLE ONCE IT WAS INSERTED. THERE WERE NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED TO OR CONTRIBUTED TO THE ISSUE. TO TROUBLESHOOT, THE PHYSICIAN REMOVED NEEDLE FROM PATIENT AND TRIED TO ADVANCE AND REMOVE THE LEAD THROUGH THE NEEDLE BUT WAS UNSUCCESSFUL. THE HCP OPENED (AN USED) A NEW LEAD KIT WHICH RESOLVED THE ISSUE. PATIENT'S WEIGHT WAS ASKED BUT UNKNOWN. THE HCP HAD NO FURTHER INFORMATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7552660 ↗
• InjuryMar 29, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURE REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT ONE OF THE PATIENT'S TRIAL LEADS CAME OUT AND THAT THE OTHER MOVED AND WAS CAUSING PAIN/DISCOMFORT. THE PATIENT WENT TO THE ER AND THE REMAINING LEAD WAS PULLED. THIS RESOLVED THE PATIENT'S PAIN. THE ISSUE WAS CONSIDERED RESOLVED AT THE TIME OF THE REPORT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Discomfort; Pain

  MAUDE report 7380973 ↗
• MalfunctionMar 20, 2018Break; Difficult to Remove; Material Deformation; Positioning Problem; Break; Difficult to Remove; Material Deformation; Positioning Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER¿S REPRESENTATIVE (REP) REGARDING A TRIAL. THE REP REPORTED THAT SHE WAS IN A TRIAL ON THE DAY OF THE REPORT AND THE HEALTHCARE PROVIDER (HCP) USED THE CURVED TIP NEEDLE. THE REP REPORTED THAT THE HCP WAS UNABLE TO GET IT INTO THE EPIDURAL SPACE AND TRIED TO PULL THE LEAD BACK AND IT WOULDN¿T COME OUT OF THE NEEDLE, SO HE HAD TO PULL OUT THE NEEDLE AND LEAD TOGETHER. THE REP REPORTED THAT THE LEAD HAD BEEN APPROXIMATELY 6 INCHES IN AND WHEN IT PULLED OUT IT APPEARED TO BE DAMAGED/BENT AND THE HCP DIDN¿T WANT TO TRY AND THREAD IT AGAIN, SO A NEW KIT WAS USED. THE REP REPORTED THAT THE PRODUCT COULDN¿T BE SENT BACK FOR ANALYSIS AS IT HAD ALREADY BEEN DISPOSED OF. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7356137 ↗
• MalfunctionFeb 14, 2018High impedance; Device Displays Incorrect Message; High impedance; Device Displays Incorrect Message

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT. IT WAS REPORTED THAT THERE WERE HIGH IMPEDANCES INTRA-OP. THE MANUFACTURER REPRESENTATIVE STATED THAT THIS CAUSED THE SYSTEM ON THAT LEAD TO DISPLAY A ¿NOT CONNECTED¿ ON THE CHECK CONNECTIVITY SCREEN. WHEN A FULL IMPEDANCE CHECK WAS PERFORMED, VALUES WERE GREATER THAN 10 ,000 OHMS ON ALL CHANNELS. IT WAS ALSO REPORTED THAT THE PHYSICIAN HAD TROUBLE ACCESSING THAT AREA DUE TO THE PATIENT¿S ANATOMY. THERE WAS MORE BLOOD THAN USUAL, AND THE MANUFACTURER REPRESENTATIVE REFERRED TO IT AS A LITTLE MORE TRAUMATIC THAN THEY WERE USED TO SEEING, SINCE THERE WERE MORE POKES AND BLOOD. IT WAS NOTED THAT ONCE THEY WERE IN, THE LEAD PLACEMENT WENT FINE. WHEN THE MANUFACTURER REPRESENTATIVE CHECKED CONNECTIVITY, THEY GOT MULTIPLE X¿S. A FULL IMPEDANCE CHECK WAS RUN, AND THE RESULTS DIDN¿T ADD UP. IT WAS NOTED THAT THEY GOT AN OUT OF REGULATION (OOR) ERROR MESSAGE REGARDLESS OF WHAT THE PATIENT WAS PROGRAMMED AT. AT THAT TIME, THEIR SETTINGS WERE AT 0.5 MA AND THE PATIENT NEVER FELT STIMULATION ON THE TABLE; THEY ONLY FELT A SLIGHT THROBBING THERE, EVEN WITH ALL ELECTRODES LIT UP. THE PATIENT¿S HEALTHCARE PROVIDER (H

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7272089 ↗
• MalfunctionDec 14, 2017Failure to Deliver Energy; Migration or Expulsion of Device; Difficult to Remove; Positioning Problem; Failure to Deliver Energy; Migration or Expulsion of Device; Difficult to Remove; Positioning Problem

  INFORMATION WAS RECEIVED REGARDING A PATIENT WITH AN EXTERNAL NEUROSTIMULATOR (ENS), AND IT WAS REPORTED THAT DURING IMPLANT THE LEAD WAS INITIALLY PLACED AT THE T8/9 LEVEL, BUT WHEN THE DOCTOR PULLED OUT THE NEEDLE THE LEAD SLIPPED TO THE T11/12 LEVEL, AND THOUGH THE DOCTOR TRIED TO ADVANCE THE LEAD, SHE WAS NOT ABLE TO GET ORIGINAL LEAD PLACEMENT. THE PATIENT HAD A GOOD TRIAL WITH SIGNIFICANT PAIN RELIEF. IT WAS ALSO REPORTED THAT THE TRIAL STIMULATOR HAD COME DETACHED FROM THE PATIENT DURING THE TRIAL, AND THE REP BELIEVED THAT THIS CAUSED FURTHER MIGRATION LEADING TO A LOSS OF STIM, HOWEVER THE REP WAS STILL ABLE TO GET THE PATIENT TO EXPERIENCE STIM AFTER THIS WITH REPROGRAMMING, BEFORE THE LEAD WAS REMOVED AT THE END OF THE TRIAL. THERE WERE NO REPORTED COMPLICATIONS AND NO FURTHER COMPLICATIONS WERE EXPECTED. PATIENT WAS IMPLANTED FOR TRIAL STIMULATION.

  Patient problems: Therapeutic Effects, Unexpected

  MAUDE report 7119175 ↗
• InjuryDec 5, 2017Difficult to Insert; Difficult to Insert

  INFORMATION WAS RECEIVED VIA A MANUFACTURING REPRESENTATIVE (REP) AND HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR (INS). INFORMATION WAS RECEIVED THAT THE MD WAS HAVING DIFFICULTY PULLING THE LEAD THROUGH NEEDLE CANULA. THE LEAD WAS EXPLANTED. THE MD OPENED NEW LEAD. NO FURTHER COMPLICATIONS WERE REPORTED. NO PATIENT SYMPTOMS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7083083 ↗
• InjurySep 15, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  INFORMATION WAS RECEIVED VIA A MANUFACTURING REPRESENTATIVE (REP) REGARDING A PATIENT WHO HAD A TRIAL LEAD. INFORMATION WAS REPORTED THAT PATIENT'S TRIAL LEAD FAILED TO WORK PROPERLY AND WAS EXPLANTED. NO FURTHER COMPLICATIONS REPORTED. NO PATIENT SYMPTOMS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6870117 ↗
• MalfunctionJun 2, 2017Device Damaged Prior to Receipt by User; Material Deformation; Adverse Event Without Identified Device or Use Problem; Positioning Problem; Device Damaged Prior to Receipt by User; Material Deformation; Adverse Event Without Identified Device or Use Problem; Positioning Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING ADVANCED PAIN CARE TRIAL LEADS. IT WAS REPORTED THAT THE INTEGRITY OF THE LEAD WAS HINDERING LEAD PLACEMENT. THE LEADS APPEARED TO BE WAVY AND NOT STRAIGHT. THE WAVY LEADS DID NOT ALLOW FOR GOOD STEERING AND LEAD PLACEMENT. THE LEADS WERE NOT IMPLANTED. ALL THE LEADS WITH THE SAME LOT NUMBER FOR THAT ACCOUNT WERE GOING TO BE RETURNED AND REPLACED. NO SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6607481 ↗
• MalfunctionJun 2, 2017Device Damaged Prior to Receipt by User; Material Deformation; Adverse Event Without Identified Device or Use Problem; Positioning Problem; Device Damaged Prior to Receipt by User; Material Deformation; Adverse Event Without Identified Device or Use Problem; Positioning Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING ADVANCED PAIN CARE TRIAL LEADS. IT WAS REPORTED THAT THE INTEGRITY OF THE LEAD WAS HINDERING LEAD PLACEMENT. THE LEADS APPEARED TO BE WAVY AND NOT STRAIGHT. THE WAVY LEADS DID NOT ALLOW FOR GOOD STEERING AND LEAD PLACEMENT. THE LEADS WERE NOT IMPLANTED. ALL THE LEADS WITH THE SAME LOT NUMBER FOR THAT ACCOUNT WERE GOING TO BE RETURNED AND REPLACED. NO SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6607468 ↗
• MalfunctionJun 2, 2017Device Damaged Prior to Receipt by User; Material Deformation; Adverse Event Without Identified Device or Use Problem; Positioning Problem; Device Damaged Prior to Receipt by User; Material Deformation; Adverse Event Without Identified Device or Use Problem; Positioning Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING ADVANCED PAIN CARE TRIAL LEADS. IT WAS REPORTED THAT THE INTEGRITY OF THE LEAD WAS HINDERING LEAD PLACEMENT. THE LEADS APPEARED TO BE WAVY AND NOT STRAIGHT. THE WAVY LEADS DID NOT ALLOW FOR GOOD STEERING AND LEAD PLACEMENT. THE LEADS WERE NOT IMPLANTED. ALL THE LEADS WITH THE SAME LOT NUMBER FOR THAT ACCOUNT WERE GOING TO BE RETURNED AND REPLACED. NO SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6607460 ↗
• MalfunctionJun 2, 2017Device Damaged Prior to Receipt by User; Material Deformation; Adverse Event Without Identified Device or Use Problem; Positioning Problem; Device Damaged Prior to Receipt by User; Material Deformation; Adverse Event Without Identified Device or Use Problem; Positioning Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING ADVANCED PAIN CARE TRIAL LEADS. IT WAS REPORTED THAT THE INTEGRITY OF THE LEAD WAS HINDERING LEAD PLACEMENT. THE LEADS APPEARED TO BE WAVY AND NOT STRAIGHT. THE WAVY LEADS DID NOT ALLOW FOR GOOD STEERING AND LEAD PLACEMENT. THE LEADS WERE NOT IMPLANTED. ALL THE LEADS WITH THE SAME LOT NUMBER FOR THAT ACCOUNT WERE GOING TO BE RETURNED AND REPLACED. NO SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6607455 ↗
• MalfunctionJun 2, 2017Device Damaged Prior to Receipt by User; Material Deformation; Adverse Event Without Identified Device or Use Problem; Positioning Problem; Device Damaged Prior to Receipt by User; Material Deformation; Adverse Event Without Identified Device or Use Problem; Positioning Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING ADVANCED PAIN CARE TRIAL LEADS. IT WAS REPORTED THAT THE INTEGRITY OF THE LEAD WAS HINDERING LEAD PLACEMENT. THE LEADS APPEARED TO BE WAVY AND NOT STRAIGHT. THE WAVY LEADS DID NOT ALLOW FOR GOOD STEERING AND LEAD PLACEMENT. THE LEADS WERE NOT IMPLANTED. ALL THE LEADS WITH THE SAME LOT NUMBER FOR THAT ACCOUNT WERE GOING TO BE RETURNED AND REPLACED. NO SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6607449 ↗
• MalfunctionJun 2, 2017Device Damaged Prior to Receipt by User; Material Deformation; Adverse Event Without Identified Device or Use Problem; Positioning Problem; Device Damaged Prior to Receipt by User; Material Deformation; Adverse Event Without Identified Device or Use Problem; Positioning Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING ADVANCED PAIN CARE TRIAL LEADS. IT WAS REPORTED THAT THE INTEGRITY OF THE LEAD WAS HINDERING LEAD PLACEMENT. THE LEADS APPEARED TO BE WAVY AND NOT STRAIGHT. THE WAVY LEADS DID NOT ALLOW FOR GOOD STEERING AND LEAD PLACEMENT. THE LEADS WERE NOT IMPLANTED. ALL THE LEADS WITH THE SAME LOT NUMBER FOR THAT ACCOUNT WERE GOING TO BE RETURNED AND REPLACED. NO SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6607446 ↗
• MalfunctionJun 2, 2017Device Damaged Prior to Receipt by User; Material Deformation; Adverse Event Without Identified Device or Use Problem; Positioning Problem; Device Damaged Prior to Receipt by User; Material Deformation; Adverse Event Without Identified Device or Use Problem; Positioning Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING ADVANCED PAIN CARE TRIAL LEADS. IT WAS REPORTED THAT THE INTEGRITY OF THE LEAD WAS HINDERING LEAD PLACEMENT. THE LEADS APPEARED TO BE WAVY AND NOT STRAIGHT. THE WAVY LEADS DID NOT ALLOW FOR GOOD STEERING AND LEAD PLACEMENT. THE LEADS WERE NOT IMPLANTED. ALL THE LEADS WITH THE SAME LOT NUMBER FOR THAT ACCOUNT WERE GOING TO BE RETURNED AND REPLACED. NO SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6607439 ↗
• MalfunctionJun 2, 2017Device Damaged Prior to Receipt by User; Material Deformation; Adverse Event Without Identified Device or Use Problem; Positioning Problem; Device Damaged Prior to Receipt by User; Material Deformation; Adverse Event Without Identified Device or Use Problem; Positioning Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING ADVANCED PAIN CARE TRIAL LEADS. IT WAS REPORTED THAT THE INTEGRITY OF THE LEAD WAS HINDERING LEAD PLACEMENT. THE LEADS APPEARED TO BE WAVY AND NOT STRAIGHT. THE WAVY LEADS DID NOT ALLOW FOR GOOD STEERING AND LEAD PLACEMENT. THE LEADS WERE NOT IMPLANTED. ALL THE LEADS WITH THE SAME LOT NUMBER FOR THAT ACCOUNT WERE GOING TO BE RETURNED AND REPLACED. NO SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6607431 ↗

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