Vectris™ SureScan® 977A260 (UDI 00763000006501)Recalls & reported problems

Summary

The FDA's MAUDE database contains 89 adverse event reports that list this exact device (DI 00763000006501), received between Jul 2, 2018 and Jun 8, 2026 — classified as 1 death, 18 injuries, 70 malfunctions.

The most frequently reported specific device problem is “Break” (26 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 89 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 8, 2026Break; High impedance

  IT WAS REPORTED THAT THE PHYSICIAN VISUALIZED A POSSIBLE ISSUE IN THE LEAD WHERE THE COMPETITOR'S IMPLANTABLE PULSE GENERATOR SET SCREW APPEARED TO COMPROMISE THE LEAD BODY. HIGH LEAD IMPEDANCE WAS OBSERVED ON THE DAY OF SURGERY, AND IMPEDANCE TESTING WAS PERFORMED WITH REPORTED VALUES OF 23531, 29627, 34217, 28285, 25531, 21901, 20531, AND 33422; CONTACTS 0¿7 WERE REPORTED TO HAVE GOOD IMPEDANCE VALUES. IT WAS REPORTED THAT THE LEAD WAS SEATED ALL THE WAY IN THE HEADER WITH GREEN X¿S EXCEPT FOR CONTACT 13, AND THAT THE PATIENT HAD BEEN SWITCHED TO THE COMPETITOR 12-CONTACT GENERATOR WITH A LARGER HEADER, AFTER WHICH THE SET SCREW WAS TIGHTENED DOWN ONTO THE BODY OF THE LEAD. TROUBLESHOOTING WAS PERFORMED, AND IT WAS REPORTED THAT BILATERAL AND ISOLATED RIGHT-SIDED COVERAGE WAS ACHIEVED AND CLOSED LOOP SPINAL CORD STIMULATION WAS SET UP. THE ISSUE WAS REPORTED TO BE ONGOING AND UNRESOLVED. NO PATIENT INJURY OR ADVERSE OUTCOME WAS REPORTED. THE MANUFACTURER REPRESENTATIVE (REP) INDICATED THEY WOULD SEND ANY FURTHER INFORMATION AS THEY BECOME AWARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25429625 ↗
• MalfunctionMay 16, 2025Unintended Collision; Impedance Problem; Unintended Collision; Impedance Problem

  IT WAS REPORTED THAT THERE WAS AN IMPEDANCE ISSUE WITH THE IMPLANTABLE NEUROSTIMULATOR AND LEADS, SPECIFICALLY WITH ELECTRODES 4 AND 10, WHICH WERE LISTED TO AVOID DURING AN IMPEDANCE CHECK. ADDITIONALLY, THERE WAS A LOSS OF EFFICACY ASSOCIATED WITH THE DEVICE. THE CAUSE OF THESE ISSUES WAS IDENTIFIED AS A CAR ACCIDENT. TROUBLESHOOTING WAS PERFORMED BY PROGRAMMING AROUND THE IMPEDANCE ISSUE. IT IS UNKNOWN IF THE ISSUE IS RESOLVED.

  Patient problems: Insufficient Information

  MAUDE report 22035293 ↗
• MalfunctionJan 31, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT A POTENTIAL LABELING ISSUE WAS IDENTIFIED WITH A LEAD MODEL ASSOCIATED WITH A PAIN STIMULATION IMPLANTABLE PULSE GENERATOR (IPG). THE OPERATIVE NOTES REFERENCED LEAD MODEL 977A280, WHICH WAS FLAGGED AS POTENTIALLY INCORRECT, AS IT WAS SUGGESTED THE CORRECT MODEL SHOULD BE 977A260. THE CALLER REPORTED THAT THE LEAD MODEL APPEARED TO BE LISTED AS 977A280 ON A STICKER. IT WAS RECOMMENDED TO COLLECT THE IMPLANTABLE NEUROSTIMULATOR MODEL AND SERIAL NUMBER FROM THE SCREEN WHEN THE PATIENT ACCESSES MAGNETIC RESONANCE IMAGING (MRI) MODE AND TO CONFIRM THE INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21287704 ↗
• MalfunctionSep 13, 2024Material Deformation; Positioning Problem; Material Deformation; Positioning Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTI MULATOR (INS). REP STATED SURGEON STATED THAT THE LEAD WAS NOT STEERING STRAIGHT. REP STATED THE LEAD LOOKED VERY TWISTED. REP ALSO MENTIONED THAT IT WAS POSSIBLE THE BENT STYLET WASN'T IN ALL THE WAY. REP TO SEND LEAD IN. HCP DIDN'T HAVE ISSUES WITH THE OTHER 2 LEADS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20213108 ↗
• MalfunctionFeb 9, 2024High impedance; High impedance

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18681971 ↗
• InjuryOct 17, 2022Break; Break

  IT WAS REPORTED THAT LEAD WIRES HAD GOT CUT IN HALF. CAUSE WAS UNKNOWN. LEAD EXPLANTED AND REPLACED. ISSUE RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15616268 ↗
• MalfunctionSep 27, 2022Failure to Deliver Energy; High impedance; Failure to Deliver Energy; High impedance

  IT WAS REPORTED THAT PATIENT HAD A LOSS OF STIMULATION. ELECTRODE 4: 40 ,000 ELECTRODE 7: >35,000. REP REPROGRAMMED AROUND EFFECTED ELECTRODES. CAUSE UNKNOWN. ISSUE RESOLVE. IT WAS REPORTED PT CALLED BACK STATING THEY NEVER HEARD BACK FROM THE REP. REVIEWED A MESSAGE WAS SENT. REVIEWED TO CONTACT HCP TO REQUEST A REP. PT UNDERSTOOD AND WILL CONTACT THE HCP. PT MENTIONED THEY HAD PLATES 4, 5, 7 BREAK AND REP IN HI REPROGRAMMED AROUND THOSE BROKEN PLATES AND THEN IT STOPPED WORKING AGAIN. PT IS TRYING TO TALK TO REP TO EITHER REPROGRAM AGAIN OR REPLACE THE WHOLE SYSTEM. REP REPORTED PATIENT IS OUT OF STATE.

  Patient problems: Inadequate Pain Relief; Pain

  MAUDE report 15490261 ↗
• InjuryAug 29, 2022Break; Failure to Deliver Energy; Break; Failure to Deliver Energy

  IT WAS REPORTED THAT UPON ACCESS INTO POCKET, IT APPEARED LIKE LEADS WERE IN A SHARP ANGLE OUT OF HEADER OF INS. PATIENT HAD A LOSS OF STIMULATION AND RETURN OF PAIN. CONNECTIONS SHOWED MULTIPLE ELECTRODES OUT. LEADS AND BATTERY REPLACED.

  Patient problems: Pain

  MAUDE report 15312606 ↗
• MalfunctionJun 29, 2022Break; Material Twisted/Bent; Break; Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. INFORMATION WAS REPORTED THAT CONTACT 0 BENT AS THE DOCTOR WAS ATTEMPTING TO STEER AND ADVANCE THE LEAD. HE HAD BEEN SWITCHING OUT THE LEAD STYLET PRIOR TO THIS HAPPENING. IT IS UNCLEAR WHETHER OR NOT THE STYLET WAS FULLY INSERTED WHEN THIS OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14856997 ↗
• MalfunctionMar 25, 2022Break; Difficult to Insert; Break; Difficult to Insert

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). THE MANUFACTURER REPRESENTATIVE REPORTED THAT THE LEAD WAS "CATCHING" ON THE NEEDLE WHEN THEY WERE TRYING TO INSERT THE NEW LEAD. DOCTOR USED ANOTHER LEAD AND IT WORKED FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13906306 ↗
• 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 13874834 ↗
• MalfunctionMar 23, 2022High impedance; Positioning Problem; High impedance; Positioning 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 THE PATIENT WAS SCHEDULED FOR A NORMAL INS BATTERY REPLACEMENT ON (B)(6) 2022. CALLER REPORTS WHEN IMPEDANCE WAS ASSESSED ON LEAD 977A160 IMPEDANCE WAS >40K OHMS. CALLER REPORTS PHYSICIAN WAS GOING TO EXPLANT BOTH LEADS; 977A260 AND A977160 WHEN HE EXPLANTS THE INS. CALLER REPORTS PHYSICIAN COULD NOT IMPLANT TWO NEW LEADS, 977A260, THE LEADS WOULD NOT ADVANCE, PHYSICIAN DECIDED TO EXPLANT ALL SYSTEM AND ABORT THE CASE. CALLER REPORTS PATIENT CURRENTLY DO NOT HAVE ANY IMPLANTS. CALLER REPORTS HE WILL BE SENDING LEAD 977A160 FOR ANALYZE. ADDITIONAL INFORMATION WAS REPORTED THAT THE CAUSE OF BEING UNABLE TO ADVANCE THE LEADS WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13861571 ↗
• MalfunctionMar 19, 2022Unsealed Device Packaging; Device Damaged Prior to Receipt by User; Unsealed Device Packaging; Device Damaged Prior to Receipt by User

  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 BY A REP THAT THEY OPENED THE OUTER BOX OF THE LEAD WHICH WAS FULLY INTACT AND THEY NOTICED THE INNER CONTAINER THAT CONTAINED THE LEAD WAS COMPROMISED. THERE SEEMED TO BE SLIGHT DAMAGE/CRACK ON THE EDGE OF THE CONTAINER AND LOOKED TO BE A SLIGHT, TINY OPENING. WE DEEMED LEAD WAS COMPROMISED AND DID NOT OPEN THE INNER PACKAGING CONTAINING THE LEAD. LEAD WAS NOT USED/IMPLANTED. LEAD NEVER CAME IN CONTACT WITH PHYSICIAN OR PATIENT. THE LEAD WILL BE RETURNED. INFORMATION WAS RECEIVED FROM THE REP WITH THE RETURNED DEVICE TRACKING NUMBER AND MAILING DATE FOR RETURN FOR ANALYSIS OF MARCH 9, 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13826139 ↗
• InjuryFeb 28, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  INFORMATION WAS RECEIVED FROM A PATIENT VIA MANUFACTURER REPRESENTATIVE WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR FBSS UPPER LIMB/NECK AND SPINAL PAIN INDICATIONS. IT WAS REPORTED THAT PATIENT WASN'T RECEIVING TONIC STIMULATION WHERE THEY WANTED. PATIENT REPORTED FALLING FROM A LADDER. LEADS HAD MIGRATED FROM TOP OF T8 TO BOTTOM OF T9 WHEN PT FELL FROM A LADDER. LEADS WERE TESTED FOR TONIC STIMULATION AND FLUORO WAS TAKEN. LEADS WERE EXPLANTED AND REPLACED WITH NEW LEADS AND TESTED INTRA OP FOR PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13624592 ↗
• MalfunctionFeb 22, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  INFORMATION WAS RECEIVED FROM A PATIENT VIA MANUFACTURER REPRESENTATIVE WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR SPINAL PAIN INDICATIONS. IT WAS REPORTED THAT MEDTRONIC REP MET WITH PATIENT AT POSTOP APPOINTMENT. THE IMPEDANCES WERE NORMAL. PATIENT STATES HER PAIN RELIEF IS NOT WHAT IT USED TO BE. SHE TOOK A FALL TWO WEEKS AFTER SURGERY AND FORGOT TO MENTION IT TO ANYONE. AFTER VIEWING AN X-RAY IT IS APPARENT HER LEAD MIGRATED DOWN ONE VERTEBRAL BODY. I REPROGRAMMED ACCORDINGLY. SHE IS INSTRUCTED TO TRY EACH GROUP FOR A WEEK AND IF SHE DOES NOT HAVE ADEQUATE PAIN RELIEF SHE WILL COME BACK TO THE OFFICE TO DISCUSS A LEAD REVISION. PHYSICIAN IS AWARE OF THE EVENT.

  Patient problems: Inadequate Pain Relief; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13579410 ↗
• InjuryFeb 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A PATIENT VIA MANUFACTURER REPRESENTATIVE WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE LEAD WAS EXPOSED THROUGH SKIN, THE SPINAL INCISION NEVER HEALED PROPERLY, PT WAS PRESCRIBED ANTIBIOTICS. THE LEAD WAS ALSO EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13561089 ↗
• InjuryFeb 14, 2022Impedance Problem; Impedance Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13524076 ↗
• MalfunctionJan 27, 2022Material Deformation; Positioning Problem; Insufficient Device Problem Information; Material Deformation; Positioning Problem; Insufficient Device Problem Information

  THE MANUFACTURER REPRESENTATIVE REPORTED THAT THE HEALTHCARE PROVIDER HAD TRIED TO INSERT THE LEAD SEVERAL TIMES BUT WAS UNABLE TO DRIVE THE LEAD WITH DEFORMED PRODUCT. THE HEALTHCARE PROVIDER REQUESTED A NEW LEAD TO REPLACE THE DEFORMED ONE AS IT WAS UNABLE TO BE USED. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13372145 ↗
• InjuryJan 4, 2022Break; Break

  IT WAS REPORTED THE DISTAL ELECTRODE WAS SHEARED OFF BY A NEEDLE WHILE REMOVING THE LEAD. ALL ITEMS WERE REMOVED FROM THE PATIENT AND THE ELECTRODE WAS FOUND. THE ISSUE WAS RESOLVED AT THE TIME OF REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13153047 ↗
• MalfunctionDec 15, 2021Positioning Problem; Insufficient Device Problem Information; Positioning Problem; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR FBSS LEG/BACK AND SPINAL PAIN. IT WAS REPORTED THAT  THE PHYSICIAN STATED THAT THE LEADS WERE TOO SMOOTH AND DIFFICULT TO STEER WHILE IMPLANTING. THEY FELT THE LEAD WAS HARD TO MANEUVER BECAUSE OF THE VERY SMOOTH CONSISTENCY AND ALSO STATED THE STYLET HEAD WAS DIFFICULT TO STEER THE LEAD TO THE DESIRED DIRECTION. IT WAS NOTED THERE WAS DIFFICULTY STEERING THE SECOND LEAD INTO PLACE AND IT CONTINUED TO GO ANTERIOR AND ULTIMATELY THE PHYSICIAN DECIDED TO INSERT THE TUOY NEEDLE NEAR THE SAME ENTRY SITE AS THE FIRST LEAD THAT WENT POSTERIORLY WITHOUT DIFFICULTY IN THE EPIDURAL SPACE. THE ISSUE WAS RESOLVED AT THE TIME OF REPORT. IT WAS NOTED THERE WERE NO ISSUES FOR THE PATIENT OR EFFICACY OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13011149 ↗
• MalfunctionDec 15, 2021Positioning Problem; Insufficient Device Problem Information; Positioning Problem; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR FBSS LEG/BACK AND SPINAL PAIN. IT WAS REPORTED THAT  THE PHYSICIAN STATED THAT THE LEADS WERE TOO SMOOTH AND DIFFICULT TO STEER WHILE IMPLANTING. THEY FELT THE LEAD WAS HARD TO MANEUVER BECAUSE OF THE VERY SMOOTH CONSISTENCY AND ALSO STATED THE STYLET HEAD WAS DIFFICULT TO STEER THE LEAD TO THE DESIRED DIRECTION. IT WAS NOTED THERE WAS DIFFICULTY STEERING THE SECOND LEAD INTO PLACE AND IT CONTINUED TO GO ANTERIOR AND ULTIMATELY THE PHYSICIAN DECIDED TO INSERT THE TUOY NEEDLE NEAR THE SAME ENTRY SITE AS THE FIRST LEAD THAT WENT POSTERIORLY WITHOUT DIFFICULTY IN THE EPIDURAL SPACE. THE ISSUE WAS RESOLVED AT THE TIME OF REPORT. IT WAS NOTED THERE WERE NO ISSUES FOR THE PATIENT OR EFFICACY OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13011136 ↗
• MalfunctionNov 8, 2021Positioning Problem; Insufficient Device Problem Information; Positioning Problem; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT HCP COULD NOT ADVANCE THE LEAD AFTER MULTIPLE ATTEMPTS. HE SAID THE LEAD FELT DIFFERENT VERY STIFF EVEN WITH THE FLEXIBLE STYLET. HE ASKED IF MEDTRONIC WAS DOING SOMETHING DIFFERENT WITH MANUFACTURING. NEW LEAD WAS USED AND OLD LEAD WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12770208 ↗
• MalfunctionAug 24, 2021Difficult to Insert; Insufficient Device Problem Information; Difficult to Insert; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER). THE PHYSICIAN REPORTED THE LEAD N OT MOVING THROUGH THE NEEDLE AS FREELY AS IT SHOULD. HE TRIED A DIFFERENT NEEDLE AND THE PROBLEM CONTINUED. THERE WAS AN ALLEGATION THAT THE LEAD MAY BE DEFECTIVE. A NEW LEAD WAS OPENED AND IT WORKED FINE. THE LEAD WAS DISCARDED BEFORE THE MANUFACTURER REPRESENTATIVE HAD A CHANCE TO TELL THEM TO HOLD IT FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12361730 ↗
• MalfunctionJul 22, 2021Break; Break

  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 THE REP OPENED PRODUCT AND THERE IS FRAYING ON THE LEAD. A DIFFERENT LEAD WAS USED AT TIME OF IMPLANT. THE FRAYED LEAD IS TO BE RETURNED TO THE MANUFACTURER. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12211895 ↗
• MalfunctionJun 21, 2021Difficult to Insert; Difficult to Insert

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT THE CUSTOMER DISCARDED THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12033642 ↗

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