RestoreAdvanced® SureScan® 97713Recalls & reported problems

Summary

The FDA's MAUDE database contains 632 adverse event reports that list this exact device (DI 00643169109490), received between Mar 27, 2015 and Sep 29, 2026 — classified as 216 injuries, 416 malfunctions.

The most frequently reported specific device problem is “Charging Problem” (154 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 632 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Migration or Expulsion of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938806 ↗
• InjuryJun 18, 2026High impedance

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT (PT) WITH AN IMPLANTED NEUROSTIMULATOR (INS). THE REP REPORTED THAT HIGH IMPEDANCES WERE OBSERVED ON THE LEADS WHEN CONNECTED TO THE NEW BATTERY. THE LEADS WERE EXPLANTED. THEY WILL SUBMIT ANY NEW INFORMATION AS THEY BECOME AWARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25552173 ↗
• MalfunctionMay 28, 2026Improper or Incorrect Procedure or Method; Battery Problem; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT REGARDING AN IMPLANTABLE NEUROSTIMULATOR. THE REASON FOR CALL WAS THAT THE DEVICE NEEDED TO BE CHARGED OR TAKEN OUT BECAUSE IT DIDN'T WORK. PATIENT STATED THAT THEIR HOUSE BURNED DOWN AND ALL THE EQUIPMENT BURNED UP IN THE HOUSE, SO THE DEVICE HAD BEEN DEAD FOR OVER A YEAR. AGENT REVIEWED IMPLANTED NEUROSTIMULATOR'S LONGEVITY WITH THE PATIENT. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25319779 ↗
• MalfunctionApr 9, 2026Connection Problem

  IT WAS REPORTED THAT PATIENT(PT) HAD A DAMAGED DESKTOP CHARGER CORD. PT STATES THE WIRES ARE SHOWING. A REQUEST WAS SENT TO REPAIR TO REPLACE THE DESKTOP CHARGER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24826506 ↗
• MalfunctionMar 26, 2026Connection Problem; Material Integrity Problem

  INFORMATION WAS RECEIVED FROM A PATIENT REGARDING AN EXTERNAL DEVICE .THE CALLER HAD A BROKEN DESKTOP CHARGER CONNECTOR PIN. PATIENT SAID THE TIP BROKE OFF IN THE TOP OF THEIR INSR, BUT THEY WERE ABLE TO GET THE TIP OUT OF THE CHARGER'S PORT JUST FINE. PATIENT DID NOT HAVE THE DESKTOP CHARGER WITH THEM AT THE TIME OF THE CALL TO PROVIDE SERIAL NUMBER AND WAS OUT OF TOWN; DIDN'T THINK ANYONE WOULD BE ABLE TO ACQUIRE SERIAL FROM THEIR HOME ON THEIR BEHALF. AGENT ASKED, PATIENT STATED THEIR IMPLANT ONLY NEEDED TO BE CHARGED EVERY 2.5-3 WEEKS, SO THEY SHOULD BE OKAY TO WAIT UNTIL THEY ARE HOME TO CALL BACK WITH THE SERIAL INFO FOR REPLACEMENT TO BE SENT OUT.PATIENT CALLED BACK TO PROVIDE THE DESKTOP CHARGER SERIAL NUMBER.NO SYMPTOMS WERE REPORTED. A REPLACEMENT DESKTOP CHARGER WAS SENT OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24696434 ↗
• MalfunctionMar 2, 2026Overheating of Device

  INFORMATION WAS RECEIVED FROM A PATIENT (PT) REGARDING AN EXTERNAL DEVICE. PATIENT MENTIONED THEY USED ADHESIVE DISKS WITH THEIR STIMULATOR BUT IT WOULD BURN THEIR SKIN. PATIENT STATED THEY ARE NOT SURE IF IT WAS DUE TO HOW MANY TIMES THE SKIN WAS "CUT OPEN" AND HOW THIN THEIR SKIN IS BUT IT WOULD BURN THE SKIN AND CAUSE IT TO ITCH FOR HOURS OR DAYS. PATIENT STATED THEY WOULD PUT THE DISK ON AND LAY A TOWEL DOWN THEN THE PADDLE AND IT WOULD STILL IRRITATE/BURN.

  Patient problems: Burn(s); Inflammation; Itching Sensation

  MAUDE report 24482497 ↗
• InjuryFeb 16, 2026Migration or Expulsion of Device; Unintended Collision

  INFORMATION WAS RECEIVED FROM A PATIENT'S REPRESENTATIVE REGARDING AN IMPLANTABLE NEUROSTIMULATOR. THE REASON FOR CALL WAS PATIENT REP STATED THAT THE PATIENT TOOK A FALL ON (B)(6) AND THEY NOTICED AFTER THE FALL THE IMPLANT WAS IN A SLIGHTLY DIFFERENT SPOT. PATIENT REP MENTIONED THE PATIENT HAD A CT SCAN AND THEY NOTICED SOMETHING IN THE PATIENT'S ABDOMINAL AREA SO THEY WANTED TO DO AN MRI. PATIENT REP MENTIONED PATIENT NEEDED A MRI OF THEIR HEAD AND ABDOMEN AND WHEN THEY CALLED THE RADIOLOGY BUT WAS TOLD THEY CAN'T GIVE THE MRI. WHEN ASKED FOR HCP, PATIENT REP MENTIONED THAT THE HEALTHCARE PROVIDER WANTED TO GIVE THE PATIENT SHOTS AND OPIOIDS, PATIENT DECLINED AND DOESN'T GO THE THEIR HCP. AGENT WALKED PATIENT REP THROUGH CONNECTING THE PATIENT PROGRAMMER TO THE IMPLANT, PATIENT REP SAW POOR COMMUNICATION SCREEN AND PATIENT REP CONFIRMED THE ANTENNA WAS PLUGGED INTO THE PATIENT PROGRAMMER. AGENT INSTRUCTED PATIENT TO UNPLUG THE PATIENT PROGRAMMER AND THEN TRY TO SYNC THE PROGRAMMER TO THE PATIENT'S IMPLANT BUT PATIENT REP SAW EOS SCREEN. AGENT REVIEWED EOS AND LONGEVITY WITH PATIENT REP. AGENT REVIEWED MRI ELIGIBILITY AND MRI FORM HCP CAN FILL OUT. AGENT EMAIL PATIENT REP PHYSICI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24343793 ↗
• MalfunctionDec 16, 2025Environmental Compatibility Problem; Environmental Compatibility Problem

  PATIENT SAID HE HAS 75% PAIN RELIEF FOR HIS LEGS UNLESS IT'S COLD, RAINING OR VERY DAMP OUTSIDE, IN THAT CASE EVEN TURNING IT UP HIGH DIDN'T REALLY HELP WITH PAIN RELIEF. PATIENT SAID HE TRIED TO CALL HEALTHCARE PROVIDER'S (HCP) OFFICE BUT WAS TOLD THE DOCTOR NO LONGER PRACTICE AT THE FACILITY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23816969 ↗
• MalfunctionDec 10, 2025Overheating of Device; Delayed Charge Time; Overheating of Device; Delayed Charge Time

  INFORMATION WAS RECEIVED FROM A PATIENT. THE REASON FOR CALL WAS OVER THE WEEKEND THE PATIENT WENT TO CHARGE THEIR IMPLANT AND THEY GOT A PICTURE OF A DOCTOR WITH A TEMPERATURE THERMOMETER. THE PATIENT PUSHED THE BUTTON AGAIN AND THE PICTURE WENT AWAY BUT THEN A FEW MINUTES LATER WHEN CHARGING THE IMPLANT THEY GOT WHAT LOOKED LIKE A THERMOMETER MEANING THE MACHINE WAS RUNNING HOT BECAUSE IT WAS VERY WARM SO THEY TURNED IT OFF AND WAITED A LITTLE WHILE AND PROCEEDED ON WITH CHARGING. WHEN THE PATIENT GOT TO A CERTAIN POINT THE MACHINE GOT HOT AGAIN. THE ISSUE STARTED MAYBE A FEW TIMES IN THE LAST COUPLE MONTHS AND THIS WEEK IT HAPPENED TWICE SO THE PATIENT TURNED THE DEVICE OFF AND STOPPED CHARGING. PATIENT MENTIONED THAT 4 OR 5 YEARS AGO THEY CONTACTED A DIFFERENT DOCTOR AND A REPRESENTATIVE CAME TO THE DOCTOR'S OFFICE AND CHECKED ALL THE EQUIPMENT AND SENT THE PATIENT ON THEIR WAY AND TOLD THEM TO CALL BACK IF THEY HAD ANY PROBLEMS. PT MENTIONED THAT IT ALSO TOOK FOREVER TO CHARGE THE INS AND IT WAS BOTHERING THEM.

  Patient problems: Burning Sensation

  MAUDE report 23769506 ↗
• MalfunctionJul 22, 2025Intermittent Continuity; Failure to Deliver Energy; Unintended Collision; Inappropriate/Inadequate Shock/Stimulation; Intermittent Continuity; Failure to Deliver Energy; Unintended Collision; Inappropriate/Inadequate Shock/Stimulation

  PT MENTIONED THEY FELL ON FRIDAY AND SINCE THEN, THE PT GOT SHOCKED EVERY ONCE IN AWHILE AND THE STIMULATION WOULD TURN OFF BY ITSELF. TSS DISCUSSED ISSUE AND REDIRECTED TO HCP. EXPECTED ERI.

  Patient problems: Electric Shock

  MAUDE report 22568967 ↗
• InjuryJul 16, 2025High impedance; High impedance

  CALLER MENTIONED THEY MET WITH THE PATIENT (PT) ON MAY 25TH AND CALLER SAW THE PT HAD CONTACT 8 IMPEDANCE AT 10,000 BUT THE REST OF THE CONTACTS WERE WITHIN RANGE. CALLER SAID THE PT WAS GOING IN FOR A REPLACEMENT IMPLANTABLE NEUROSTIMULATOR (INS) AND WANTED TO KNOW MORE ABOUT COMPATIBILITY OF THE STIMULATOR AND EXTENSIONS. NO SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED FROM MANUFACTURER REPRESENTATIVE (REP) WHO REPORTED THE CAUSE OF PATIENT'S HIGH IMPEDANCES WERE NOT DETERMINED. THEY REPORTED THEY SPOKE WITH TECHNICAL SERVICES WHO WALKED PATIENT THROUGH ASSIGNING CORRECT LEAD ON TABLET. THEY DID NOT USE CONTACT 8 AND WAS ABLE TO PROVIDE GOOD COVERAGE FOR THE PATIENT. THEY REPORTED THE ISSUE WAS RESOLVED AS THEY PROGRAMMED USING THE OTHER CONTACTS ON THE LEAD AVOIDING CONTACT 8.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22526022 ↗
• InjuryJul 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REASON FOR CALL WAS CALLER STATED THEIR SPINAL CORD STIMULATOR (SCS) WAS REMOVED DUE TO INFECTION. CALLER STATED PATIENT HAD AN MRI IN (B)(6) 2025 AND THEY DIDN'T SEE ANY SCS COMPONENTS. PATIENT STATED SCS WAS REMOVED "10 YEAR AGO" BUT PATIENT DIDN'T PROVIDE ANY MORE SPECIFIC DATE. TROUBLESHOOTING WAS NOT REQUIRED. [SEE (B)(4) FOR ALLEGATIONS OF PATIENT'S PACEMAKER].

  Patient problems: Unspecified Infection; Weight Changes

  MAUDE report 22500174 ↗
• MalfunctionJun 30, 2025Connection Problem; Material Integrity Problem; Connection Problem; Material Integrity Problem

  IT WAS REPORTED THAT PATIENT HAD A DESKTOP CHARGER CORD WHERE THE CORD HAS FALLEN APART ON THE PIECE THAT PLUGS INTO THEIR REMOTE TO RECHARGE. THE ISSUE BEGAN SEVERAL WEEKS AGO. THE ISSUE WAS NOT RESOLVED. A REQUEST WAS SENT TO REPAIR TO REPLACE THE DESKTOP CHARGER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22356516 ↗
• MalfunctionJun 23, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR 97713 RESTORE ADVANCED HAD HIGH IMPEDANCE WAS OBSERVED ON ELECTRODES 1 AND 5. AN IMPEDANCE CHECK WAS PERFORMED ON THE CURRENT LEADS, CONFIRMING HIGH IMPEDANCE ON THESE ELECTRODES. THE HIGH IMPEDANCES WERE GREATER THAN 20 ,000. THE FINDINGS WERE COMMUNICATED TO THE PHYSICIAN DURING THE APPOINTMENT. THE PHYSICIAN DECIDED NOT TO PERFORM A LEAD REVISION SURGERY AT THIS TIME, AS PROGRAMMING COULD BE ADJUSTED TO AVOID THE AFFECTED ELECTRODES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE MANUFACTURER REPRESENTATIVE (REP) INDICATED THEY WOULD SEND ANY FURTHER INFORMATION AS THEY BECOME AWARE. SEE GENERAL TEXT FOR OMITTED INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22307357 ↗
• MalfunctionJun 20, 2025Material Frayed; Overheating of Device; Improper or Incorrect Procedure or Method; Battery Problem; Insufficient Device Problem Information; Material Frayed; Overheating of Device; Improper or Incorrect Procedure or Method; Battery Problem; Insufficient Device Problem Information

  PATIENT STOPPED RECHARGING 1.5 YEAR AGO DUE TO FRAYED CORD THAT CAUSED WARMTH WHILE RECHARGING. PATIENT IS LIKELY IN OVERDISCHARGE. TECHNICAL SERVICES(TS) ORDERED RECHARGER ANTENNA, AND REPRESENTATIVE (REP) WILL MEET WITH PATIENT TO GET HIM OUT OF OVERDISCHARGE WITH PHYSICIAN RECHARGE MODE. PATIENT NEEDS MRI FOR BRAIN TUMOR, BUT HE'S BEEN DENIED THE MRI SINCE HE CAN'T PUT HIS SYSTEM INTO MRI MODE. TS REVIEWED ELIGIBILITY FORM. REP TO MEET WITH PATIENT TO GET SYSTEM OUT OF OVER DISCHARGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22294892 ↗
• InjuryApr 4, 2025High impedance; Impedance Problem; High impedance; Impedance Problem

  ADDITIONAL INFORMATION WAS RECEIVED, IT WAS REPORTED THE CAUSE OF THE EVENT WAS NOT DETERMINED. THE HIGH IMPEDANCE ISSUE WAS NOT RESOLVED AND THE LEAD WAS EXPLANTED AND REPLACED WITH PERCUTANEOUS LEADS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21775226 ↗
• InjuryFeb 4, 2025Failure to Deliver Energy; Battery Problem; Patient Device Interaction Problem; Failure to Deliver Energy; Battery Problem; Patient Device Interaction Problem

  INFORMATION WAS RECEIVED FROM A PATIENT (PT) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REASON FOR CALL WAS THAT THEY NOTICED THAT THE INS WENT DEAD AND SO THEY RECHARGED THE INS FOR THREE HOURS, HOWEVER THEY HAD TO TURN A CERTAIN WAY IN ORDER TO FEEL THE STIMULATION. PT THEN STATED THAT IT WOULDN'T CHARGE; PSS CLARIFIED FURTHER WITH THE PT AND ASKED THE PT IF THEY WERE ABLE TO SUCCESSFULLY RECHARGE THE INS AND PT STATED THAT THE INS BATTERY WAS CURRENTLY HALF CHARGED, SO PSS WAS UNDERSTANDING THAT THE INS CHARGED PROPERLY FROM THE EQUIPMENT. PT STATED THAT THE STIMULATION WOULD DO A LITTLE BIT IN THEIR LEGS, HOWEVER THEN THE STIMULATION WOULD SHUT OFF AND THEN IF THEY TURNED ANOTHER CERTAIN WAY, THE STIMULATION WOULD DO THE SAME THING. WHEN PSS ASKED THE PT FOR THE EVENT DATE, PT STATED THAT THE ISSUE STARTED LAST NIGHT AND THAT THE STIMULATOR WASN'T WORKING LIKE IT WAS LAST WEEK BEFORE THE INS WENT DEAD. PSS ADVISED THE PT TO FOLLOW-UP WITH HCP OR A MDT REP FOR POSSIBLE INS REPROGRAMMING ONCE THE REPLACEMENT PROGRAMMER HAS BEEN RECEIVED AND IF THEY ARE STILL EXPERIENCING THE REPORTED ISSUE. PATIENT CALLED BACK FROM REGISTERED PHONE NUMBER TO SAY THAT SHE WAS HAVING SAME

  Patient problems: Insufficient Information

  MAUDE report 21306951 ↗
• InjuryFeb 3, 2025Break; Therapy Delivered to Incorrect Body Area; Adverse Event Without Identified Device or Use Problem; Break; Therapy Delivered to Incorrect Body Area; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP). REP REPORTED THAT THE INS WAS EXPLANTED DUE TO ERI AND THE OLD LEADS WERE SET TO BE EXCHANGED BECAUSE THERE WAS HIGH IMPEDANCES IN THE UPPER LEADS. REP REPORTED THE TWO MOST DISTAL LEADS BROKE OFF OF THE LEAD AND WERE NOW IN THE EPIDURAL SPACE STILL. THE DEVICE HAS NOT BEEN SHIPPED BACK AND THE LEAD WAS THROWN AWAY.

  Patient problems: Device Embedded In Tissue or Plaque; Insufficient Information; Undesired Nerve Stimulation

  MAUDE report 21294342 ↗
• InjuryJan 29, 2025Break; Battery Problem; Break; Battery Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP). REP REPORTED THAT THEY BECAME AWARE OF THE ISSUE ON MARCH 4, 2025. REP REPORTED THAT THE CAUSE OF THE ELECTRODES NOT WORKING WAS UNKNOWN, BUT PERHAPS FROM A POSSIBLE FALL. REP NOTED TO RESOLVE THE ISSUE, THEY REPROGRAMMED THE DEVICE BY UTILIZING THE GOOD LEAD AND BATTERY REPLACEMENT AS THE PT DID NOT WANT A PADDLE OR LEAD REVISION. REP REPROGRAMMED THE PT AND THEY WERE HAPPY WITH THEIR CURRENT PROGRAMS. THE INFORMATION HAS BEEN CONFIRMED WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21264356 ↗
• MalfunctionJan 23, 2025Improper or Incorrect Procedure or Method; Battery Problem; Charging Problem; Improper or Incorrect Procedure or Method; Battery Problem; Charging Problem

  (B)(6)2024: INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT (PT) WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REASON FOR CALL WAS CALLER STATED INS WAS DEPLETED AND PATIENT HAS BEEN UNABLE TO CHARGE IT FOR 2 YEARS. PATIENT STATED THEY NEEDED AN MRI OF THEIR HEAD AND CERVICAL SPINE, BUT THE INS HAD BEEN DEAD FOR A LITTLE OVER A YEAR. AGENT ASKED, PATIENT CLARIFIED THEY HADN'T NEEDED INS FOR A MONTH OR MONTH AND A HALF AND WHEN THEY TRIED TO CHARGE AGAIN, THEY COULDN'T. PATIENT STATED THE DOCTOR'S OFFICE THOUGHT PATIENT NEEDED TO HAVE THE INS TURNED OFF OR REMOVED. AGENT REVIEWED MRI GUIDELINES AND REVIEWED OPTION TO ADDRESS POSSIBLE OVER DISCHARGE OR HAVE DOCTOR FILL OUT ELIGIBILITY FORM. (B)(6)2025: ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. THEY REPORTED THAT THEY ASSUMED THE DEVICE DIED, THEY WERE UNABLE TO CHARGE. NOTHING WAS DONE, THE UNIT WAS 8 YEARS AND A FEW MONTHS. THEY WERE TOLD LIFE WAS 9 YEARS. PATIENT STATED THEY NEED IT REMOVED DUE TO NEEDING AN MRI TO DIAGNOSE PROBLEMS THEY HAVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21218665 ↗
• MalfunctionDec 6, 2024Inappropriate/Inadequate Shock/Stimulation; Malposition of Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Inappropriate/Inadequate Shock/Stimulation; Malposition of Device; Insufficient Device Problem Information; Patient Device Interaction Problem

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE REASON FOR CALL WAS PATIENT SAID FOR ABOUT THE LAST 3 WEEKS WHEN THEY BEND OVER, THEY GET A JOLT IN THE MIDDLE OF THEIR BACK. PT STATED THEY SAW HCP YESTERDAY WHO TOLD THEM TO GET A REP.

  Patient problems: Electric Shock; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20864289 ↗
• InjuryNov 5, 2024Migration or Expulsion of Device; Unstable; Charging Problem; Patient Device Interaction Problem; Migration or Expulsion of Device; Unstable; Charging Problem; Patient Device Interaction Problem

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). CALLER MENTIONED HISTORICAL INFORMATION THAT WHEN THEY PUT THE FIRST IMPLANT IN, IT WOULDN'T CHARGE BECAUSE IT WAS PUT IN THEIR BUTT CHEEK AND THE IMPLANT WOULD FLIP WHEN THEY SAT ON THE TOILET. CALLER SAID THEY HAD TO GO BACK INTO SURGERY A COUPLE TIMES TO TRY AND TETHER IT TO THE TISSUE AND FINALLY IT MIGRATED FROM THE MIDDLE OF THE BUTT UP TO THE RIGHT SIDE OF THEIR SPINE AT THEIR WAIST. CALLER MENTIONED THAT THEY USED TO BE THIN BUT GAINED A LOT OF WEIGHT BECAUSE OF THEIR BACK ISSUES. AGENT REVIEWED ROLE OF MANUFACTURER AND DOCUMENTED REPORTED INFORMATION. AGENT REVIEWED PHYSICIAN LOCATOR WEBSITE IF CALLER FEELS THEY NEED TO FIND ANOTHER SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20609545 ↗
• MalfunctionOct 2, 2024Energy Output Problem; Energy Output Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). TS REVIEWED WHEN PATIENT WILL TRIGGER ERI AND EOS. REP STATES PATIENT IS AT 3.84V. REP STATES THE PATIENT HAS NORMAL IMPEDANCES, BUT TWO ELECTRODES THAT ARE AT 3635 AND 4388 OHMS. REP STATES THEIR PROGRAMMING WAS USING THESE ELECTRODES, BUT THE PATIENT WAS EXPERIENCING INTERMITTENT INTERRUPTIONS IN THEIR THERAPY. SINCE BEING RE-PROGRAMMED, THIS IS NO LONGER OCCURRING.

  Patient problems: Insufficient Information

  MAUDE report 20352731 ↗
• InjurySep 23, 2024Failure to Deliver Energy; Battery Problem; Failure to Deliver Energy; Battery Problem

  INFORMATION WAS RECEIVED FROM A PATIENT (PT) WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REASON FOR CALL WAS PATIENT REPORTED THEY ARE NOT FEELING STIMULATION ON THE RIGHT SIDE OF THEIR BODY SINCE A COUPLE DAYS AGO. PATIENT STATED THE LEFT SIDE IS WORKING. PATIENT SERVICE ASKED IF PATIENT HAD A FALL OR TRAUMA AND PATIENT SAID IN THE LAST COUPLE YEARS. AGENT ASKED PATIENT TO CONNECT WITH THE CONTROLLER AND PATIENT SAID THE CONTROLLER SHOW THE IMPLANT IS ON AND THEY CAN ADJUST THE STIMULATION ON BOTH SIDES, BUT WHEN THEY INCREASE THE STIMULATION ON THE RIGHT SIDE THEY ARE NOT FEELING STIMULATION. AGENT REVIEWED PATIENT SERVICES ROLE. THE ISSUE WAS NOT RESOLVED. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER (HCP) TO FURTHER ADDRESS THE ISSUE. ON (B)(6) 2024 PT CALLED BACK AND RE-REPORTED NOT FEELING STIMULATION ON THE RIGHT SIDE OF THEIR BODY. PT REPORTED THE STIMULATION STOPPED WORKING ON THE RIGHT SIDE ABOUT SEPTEMBER 2ND AND THEY COULDN'T GET A HOLD OF ANYONE BECAUSE OF THE HOLIDAYS, SO THEY FINALLY GOT TOGETHER WITH THEIR REP TODAY. THEY MET BECAUSE THEIR STIMULATOR WASN'T WORKING AND WAS TO CALL PATIENT SERVICES TO REQUEST A PROGRAMMER REPLACEMENT,

  Patient problems: Insufficient Information

  MAUDE report 20280042 ↗
• MalfunctionSep 20, 2024Break; Break

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). PATIENT REPORTED THEY HAD A LEAD BREAK OVER THE YEARS. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20267062 ↗

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