PrimeAdvanced® SureScan® MRI 97702Recalls & reported problems

Summary

The FDA's MAUDE database contains 242 adverse event reports that list this exact device (DI 00643169974883), received between Jul 8, 2019 and Jul 8, 2026 — classified as 126 injuries, 116 malfunctions.

The most frequently reported specific device problem is “High impedance” (52 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 25 most recent of 242 reports, in the reporter's own words as published by the FDA.

• InjuryJul 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH IMPLANTABLE NEUROSTIMULATORS EXPERIENCED INCISION REOPENING WITH THE INCISION SPLIT OPEN. THE LEADS WERE PARTIALLY REMOVED PRIOR TO THE FULL EXPLANT, AND THE PHYSICIAN SUBSEQUENTLY REMOVED THE ENTIRE SYSTEMS. THE PATIENT WAS REPORTED ALIVE WITH NO INJURY, AND THE ISSUE WAS REPORTED AS RESOLVED. NO PATIENT COMPLICATIONSHAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE MANUFACTURER REPRESENTATIVE (REP) INDICATED THEY WOULD SEND ANY FURTHER INFORMATION AS THEY BECOME AWARE.

  Patient problems: Wound Dehiscence

  MAUDE report 25751296 ↗
• MalfunctionJun 8, 2026Intermittent Continuity; Failure to Deliver Energy; Malposition of Device

  INFORMATION WAS RECEIVED FROM A PATIENT REGARDING AN IMPLANTABLE NEUROSTIMULATOR. THE REASON FOR CALL WAS PATIENT REPORTED THEIR STI MULATION WAS SHUTTING OFF ON THEM AND THE ISSUES FOR BOTH THEIR IMPLANT BEGAN ABOUT A MONTH AGO. PATIENT STATED THE LEFT IMPLANT SHUT OFF TWICE AND THE RIGHT IMPLANT DID IT ONCE. PATIENT HAD AN APPOINTMENT WITH THEIR HEALTHCARE PROVIDER ON THE (B)(6) BECAUSE THE RIGHT BATTERY PACK FELT LIKE IT WAS PULLING AT THE WIRES AND IT GOT TO A POINT WHERE IT WAS PAINFUL AND THAT WAS THE LEAST OF THEIR PROBLEM. PATIENT LOST 105 POUNDS IN THE LAST 1.5 YEARS AND NOW BOTH BATTERY PACKS WERE COMPLETELY VISIBLE AND MORE EXPOSED NEITHER ONE OF THEM WERE QUITE COMFORTABLE ANYMORE. THE IMPLANT ON THEIR BUTT LITERALLY FELT LIKE IT WAS PULLING IT. AGENT REDIRECTED PATIENT TO THEIR HEALTHCARE PLAN TO FURTHER ADDRESS THE ISSUE. PATIENT MENTIONED IT HAD BEEN 5 YEARS AND USUALLY THAT WAS HOW LONG THEY GOT BEFORE THE BATTERY STARTED TO GO.

  Patient problems: Discomfort; Insufficient Information; Pain

  MAUDE report 25428761 ↗
• MalfunctionMar 30, 2026Low impedance

  INFORMATION WAS RECEIVED FROM A MANUFACTURER'S REPRESENTATIVE REGARDING AN IMPLANTABLE NEUROSTIMULATOR. THE REASON FOR CALL WAS CALLER REPORTED THAT FOR THE LAST 6-8 MONTHS, PATIENT HASN'T BEEN GETTING THE RELIEF LIKE THEY USE TO AND THEY'VE HAD TO INCREASE THE AMPLITUDE TO TRY AND GET MORE RELIEF. CALLER STATED THEY CHECKED IMPEDANCES AND ONE ELECTRODE (CONTACT 12) WAS LESS THAN 50. CALLER MENTIONED OTHER ELECTRODES, 11 AND 13, WERE AROUND 400 AND THE REST WERE AROUND 500. TECHNICAL SERVICES DIDN'T CLARIFY WHICH REFERENCE ELECTRODE WAS BEING USED. CALLER WAS ABLE TO PROGRAM AROUND IT AND OBTAIN COVERAGE. CALLER STATED THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. AGENT SUGGESTED THAT ONCE IMPLANTABLE NEUROSTIMULATOR REACHES END OF SERVICE, THEY MAY WANT TO PERFORM INTRA-OP TESTING OF THE LEADS AS THE LEAD(S) MAY NEED TO BE REPLACED TO RESOLVE THE LOW IMPEDANCE.

  Patient problems: Insufficient Information

  MAUDE report 24728112 ↗
• InjuryJan 26, 2026Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE INS WA S REPLACED YESTERDAY. CALLER FOUND A NON-OPERATIVE NOTE FROM YESTERDAY THAT SAID PATIENT COMPLAINED OF "REFRACTORY OAB." CALLER WENT ON TO READ IN THAT NOTED THAT PATIENT HAD A "DUAL LEAD SNM IN 2010," "REVISED IN 2019," AND "STOPPED WORKING IN 2024." CALLER FOUND A NOTE FROM 2024 WHERE PATIENT SPOKE WITH HEALTHCARE PROVIDER (HCP) ABOUT POSSIBILITY OF IMPLANT REVISION/REPLACEMENT AT SOME POINT AND VOICED INTEREST IN A PELVIC HEALTH STIMULATOR. CALLER FINALLY FOUND AN OPERATIVE NOTE FROM YESTERDAY THAT SAID "REMOVAL OF OLD DUAL LEAD SNM GENERATOR," THAT WAS "COMPLETELY INTACT WITH NO FRAGMENTATION."

  Patient problems: Urinary Frequency / Polyuria

  MAUDE report 24176996 ↗
• InjuryDec 11, 2025Migration or Expulsion of Device; Unintended Collision; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Unintended Collision; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A PATIENT (PT) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REASON FOR CALL WAS THE PATIENT REPORTED THEY WANTED THEIR IMPLANT REMOVED DUE TO IT CAUSING THEM EXTREME PAIN AND INFECTION, AND WANTED ASSISTANCE WITH FINDING A WAY TO REMOVE THE IMPLANT. PATIENT STATED THE ISSUE STARTED AROUND 3-4 MONTHS AGO. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER (HCP) TO FURTHER ADDRESS THE ISSUE. PATIENT DID NOT HAVE A CURRENT MANAGING PHYSICIAN, SO AGENT REQUESTED FOR A PHYSICIAN LIST TO BE MAILED TO THE PATIENT'S NEW ADDRESS (UPDATED WITH PRS VIA EMAIL). PATIENT MENTIONED THEY HAD A SURGEON WHO WAS CONCERNED THAT THESE SURGERIES CAN CAUSE INFECTION.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 23779701 ↗
• MalfunctionNov 20, 2025Failure to Deliver Energy; Unintended Collision; Failure to Deliver Energy; Unintended Collision

  INFORMATION WAS RECEIVED FROM A PATIENT'S REPRESENTATIVE REGARDING AN IMPLANTABLE NEUROSTIMULATOR. THE REASON FOR CALL WAS CALLER REPORTED FOR THE PAST 3-4 WEEKS THE PATIENT HAD LEG AND HIP PAIN. CALLER STATED THE PATIENT WAS IN A NURSING HOME AND ON HOSPICE BUT WAS SENT TO THE HOSPITAL FOR THE PAIN AND THEY DID XRAYS AND ALL OF THAT WAS FINE, BUT PATIENT IS STILL HAD PAIN WHICH THEY USUALLY DON'T. CALLER STATED THEY ATTEMPTED TO HAVE THEM TURN THE PATIENT'S THERAPY UP, BUT THE PATIENT COULD NOT FEEL THE STIMULATION. CALLER ALSO INDICATED HAVING SEEN AN ERROR MESSAGE BUT WAS UNABLE TO CLARIFY OR PROVIDE ANY DETAILS OF THE MESSAGE. CALLER COMMENTED THE PATIENT'S LAST IMPLANT BATTERY LASTED 10 YEARS. CALLER STATED THE PATIENT HAD LOST LIKE 80 POUNDS AND HAD MULTIPLE FALLS, SO THE IMPLANT MAY HAVE BEEN DAMAGED OR MOVED. THE PATIENT WAS REDIRECTED TO MDT REP AND HCP TO FURTHER ADDRESS.

  Patient problems: Pain

  MAUDE report 23607007 ↗
• InjurySep 2, 2025High impedance; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; High impedance; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). THEY STATED THEY WERE UNABLE TO UTILIZE THE CONTACTS AT THE TOP OF THE LEAD THAT WERE AVAILABLE BEFORE AND THAT THE CAUSE OF THE MIGRATION IS UNKNOWN. REP TRIED TO REPROGRAM, BUT THE DOCTOR STATED HE WILL DO A LEAD REVISION SURGERY. THE DOCTOR IS DECIDING IF HE REPLACES BOTH THE IMPLANT AND LEADS. REP DISCUSSED IT WITH DOCTOR, AND THE DOCTOR WILL DECIDE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22938843 ↗
• InjuryAug 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THE IMPLANT GOT AN INFECTION 2 WEEKS AFTER IMPLANT AND WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 22738609 ↗
• MalfunctionJul 30, 2025Failure to Interrogate; Communication or Transmission Problem; Insufficient Device Problem Information; Failure to Interrogate; Communication or Transmission Problem; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT'S REPRESENTATIVE REGARDING AN IMPLANTABLE NEUROSTIMULATOR. IT WAS REPORTED THAT THE PATIENT NEEDS AN MRI AND THEY ARE NOT ABLE TO ENTER MRI MODE. CALLER STATED THAT THEY ARE SEEING THE POOR COMMUNICATION SCREEN ON THE PATIENT PROGRAMMER. AGENT HAD THE CALLER REPOSITION THE PROGRAMMER OVER THE IMPLANT AND TRY AGAIN. CALLER STATED THEY HAD NOT USED OR ATTEMPTED TO CONNECT TO THE IMPLANT IN 4 YEARS. AGENT PROVIDED AN MRI ELIGIBILITY FORM AND REDIRECTED THEM TO THEIR MANAGING HEALTHCARE PROVIDER (HCP). CALLER STATED THE THERAPY HAD NOT BEEN PROVIDING EFFECTIVE RELIEF FOR THE PATIENT FOR THE PAST 4 YEARS.

  Patient problems: Insufficient Information

  MAUDE report 22669041 ↗
• MalfunctionJun 11, 2025Intermittent Continuity; High impedance; Unintended Collision; Insufficient Device Problem Information; Intermittent Continuity; High impedance; Unintended Collision; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT FELL ON THEIR BACK APPROXIMATELY ONE YEAR AGO AND THE IMPLANTABLE NEUROSTIMULATOR HAS NOT WORKED PROPERLY SINCE THE FALL. THE PATIENT SUSPECTED AN ISSUE WITH THE LEAD AND REPORTED THAT STIMULATION WAS NOT WORKING PROPERLY FOR A COUPLE OF WEEKS PRIOR TO THE REPORT. THE PATIENT WAS REDIRECTED TO THEIR MANAGING HEALTHCARE PROVIDER.

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

  MAUDE report 22187075 ↗
• MalfunctionMay 5, 2025Malposition of Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Malposition of Device; Insufficient Device Problem Information; Patient Device Interaction Problem

  THE PATIENT (PT) REPORTED THAT SINCE IMPLANT THEIR IMPLANTED NEUROSTIMULATOR (INS) HAD NEVER REALLY WORKED GOOD. THEY HAD TRIED ADJ USTING THERAPY, BUT THEY ENDED UP STOPPING THE USE OF THE DEVICE 3 YEARS PRIOR TO THIS CALL. THE PT EXPLAINED THAT THE INS WAS REALLY BIG AND WHEN THEY TWISTED A CERTAIN WAY, IT GOT STUCK AND THE PT WOULD CRAMP. THE PT CONFIRMED THAT AFTER THEY TURNED THE THERAPY OFF, THEY WOULD NOT EXPERIENCE THIS. THE PT REPORTED THEY THINK THE INS WAS NOT PUT IN THE RIGHT SPOT. THE PT ADDED THAT THEY NEED AN MRI DUE TO A SPINE INJURY, AND THEY NEEDED A NEW PROGRAMMER. MRI GUIDELINES WERE REVIEWED WITH THE PT AND PHYSICIAN LISTINGS WERE SENT TO THE PT. THE PT WAS REDIRECTED TO SUNMED TO REQUEST A REPLACEMENT PROGRAMMER.

  Patient problems: Cramp(s) /Muscle Spasm(s)

  MAUDE report 21961636 ↗
• InjuryApr 30, 2025Battery Problem; Battery Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM MANUFACTURER REPRESENTATIVE (REP) WHO REPORTED PATIENT HAS A NON-RECHARGEABLE DEVICE. REP STATED THE DEVICE REMOVAL HAS NOT BEEN PLANNED YET AND THEY ARE WAITING ON AN MRI FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21937953 ↗
• MalfunctionApr 21, 2025Failure to Deliver Energy; Insufficient Device Problem Information; Patient Device Interaction Problem; Failure to Deliver Energy; Insufficient Device Problem Information; Patient Device Interaction Problem

  INFORMATION WAS RECEIVED FROM A PATIENT (PT) WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REASON FOR THE CALL WAS IN THE LAST WEEK THE PT'S STIMULATOR WAS NOT WORKING RIGHT. WHEN THE PATIENT USED THEIR PATIENT PROGRAMMER TO ADJUST THEIR THERAPY, THEY WERE NOT FEELING RELIEF. THE PATIENT SAID THEY COULD FEEL THE STIMULATION SOMETIMES BUT NOT ALL THE TIME. A SUDDEN MOVE WOULD ALLOW THEM TO KNOW IT WAS ON SINCE THEY COULD FEEL STIMULATION SOMETIMES BUT NOT ALL THE TIME. THE PATIENT MENTIONED THAT THEY HAD ONE OF THEIR IMPLANTS DIE BEFORE AND THEY KNEW WHAT THAT FELT LIKE SO THEY HAD A FEELING THIS INS BATTERY WAS DYING AS WELL. THE PT WANTED TO FIND A DOCTOR THAT CAN WORK WITH THEIR DEVICE. AGENT EMAILED PATIENT PHYSICIAN LISTINGS.

  Patient problems: Insufficient Information

  MAUDE report 21877974 ↗
• InjuryApr 1, 2025Battery Problem; Battery Problem

  INFORMATION WAS RECEIVED FROM A FRIEND/FAMILY MEMBER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REASON FOR CALL WAS CALLER STATED THAT THE PATIENT RECEIVED A CALL TO HAVE AN MRI AND THEY WANTED TO KNOW IF THERE WAS A WAY TO PUT THE IMPLANT INTO MRI MODE. CALLER MENTIONED THE PATIENT HASN'T USED THE EQUIPMENT IN YEARS AND DON'T KNOW WHERE THE PATIENT PROGRAMMER IS OR WHERE THE CHARGER IS. AGENT ASKED IF PATIENT HAD USED THE IMPLANT RECENTLY AND CALLER NOTED PATIENT HAD NOT USED THE IMPLANT IN THE PAST 3-4 YEARS. CALLER STATED AFTER THE IMPLANT SURGERY THE STIMULATOR DID NOT HELP AT ALL AND DIFFERENT REPS TRIED TO REPROGRAM IT. CALLER REPORTED THE PATIENT HAS AN APPOINTMENT ON (B)(6) WITH A NEUROSURGEON TO HAVE THE IMPLANT TAKEN OUT; CALLER ADDED THEY WERE REFERRED BY THE PAIN MANAGEMENT DOCTOR. AGENT REVIEWED MRI MODE AND JUMP STARTING THE IMPLANT AND THAT THE IMPLANT WAS LIKELY DEAD. AGENT ADVISED CALLER TO HAVE THE IMPLANT REMOVED BEFORE GETTING THE MRI. WHEN ASKED FOR AN EVENT DATE; CALLER MENTIONED PROBABLY THE LAST 3 YEARS AT LEAST. CALLER FOLLOWED UP SAYING THAT THE LAST DOCTOR THEY SAW REFERRED THEM TO THE NEUROSURGEON.

  Patient problems: Insufficient Information

  MAUDE report 21737379 ↗
• MalfunctionMar 21, 2025Impedance Problem; Impedance Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). CALLER HAS OP NOTE FROM IMPLANT SURGERY: "LEADS WERE REMOVED FROM THE OLD GENERATOR AND CONNECTED TO A NEW IMPLANTABLE GENERATOR. IMPEDANCE CHECK WAS DONE AND SHOWED ONE OF THE LEADS TO BE FINE BUT THE LEAD WAS OUT OF RANGE. THAT LEAD WAS REMOVED AND CLEANED AND RE-INSERTED. IT WAS AGAIN COMPLETELY OUT OF RANGE. WE THEN SWITCHED THE LEADS IN THE GENERATOR. ONCE GAIN ONE OF THE LEADS WAS FINE AND THE OTHER WAS OUT OF RANGE. THE FUNCTIONAL LEAD WAS IN 0-7 AT THIS POINT THE POCKET WAS COPIOUSLY IRRIGATED WITH ANTIBIOTIC SOLUTION MULTIPLE TIMES. THE POCKET DID HAVE TO BE ENLARGED SOMEWHAT. AS WE WERE GOING FROM A RECHARGEABLE TO A PRIMARY CELL GENERATOR. THIS ENLARGEMENT WAS DONE PRIOR TO IRRIGATION. GENERATOR WAS PLACED IN THE POCKET WITH EXCESS LEAD COILED BEHIND."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21665635 ↗
• InjuryFeb 26, 2025High impedance; High impedance

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). REP. SAID THEY MET WITH PT ABOUT A WEEK AGO AND INTERROGATED INS AND FOUND THAT THE PT HAD A HIGH IMPEDANCE(POSSIBLY OVER 40, 000) ON CONTACT 0. PT WAS GETTING INS REPLACED AND REP. CALLED FOR MORE INFORMATION ABOUT PRODUCT COMPATIBILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21468882 ↗
• InjuryFeb 19, 2025Migration or Expulsion of Device; Energy Output Problem; Migration or Expulsion of Device; Energy Output Problem

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REASON FOR CALL WAS PATIENT STATED THEY WANTED TO CHECK TO SEE IF THEIR STIMULATOR WAS WORKING AS PATIENT DIDN'T THINK IT WAS. PATIENT SAID THEY HAD MASSIVE ISSUES. PATIENT CLARIFIED THEY WERE HAVING INTENSE PAIN BEHIND THEIR RIGHT EAR, IN THEIR NECK, ABOVE AND BELOW THEIR EYES, AND WERE SENSITIVE TO LIGHT ON THE RIGHT SIDE. PATIENT CONFIRMED THESE WERE THE SYMPTOMS THE STIMULATOR IS SUPPOSED TO HELP WITH. PATIENT SAID THEIR DOCTOR WAS IN ANOTHER STATE, SO THEY WANTED TO CHECK OVER THE PHONE FIRST BEFORE HAVING TO GO OUT TO THEIR DOCTOR. PATIENT DID NOT HAVE THEIR PROGRAMMER WITH THEM AT THE TIME OF THE CALL AS THEY SAID THEY WERE IN THE PROCESS OF MOVING AND THE PROGRAMMER WAS PACKED AWAY. AGENT REVIEWED IF PATIENT COULD FIND THE PROGRAMMER, PATIENT COULD CALL BACK FOR HELP CHECKING IMPLANT/THERAPY STATUS OVER THE PHONE, OTHERWISE THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE. PT CALLED BACK STATING THEY DID NOT FIND THEIR PROGRAMMER AND WOULD LIKE THE MANUFACTURER REPRESENTATIVE (REP) TO COME OUT AND CHECK THEIR DEVICE. PT WOULD LIKE TO M

  Patient problems: Hyperresponsive to stimuli; No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 21414348 ↗
• MalfunctionFeb 19, 2025Inappropriate/Inadequate Shock/Stimulation; Adverse Event Without Identified Device or Use Problem; Inappropriate/Inadequate Shock/Stimulation; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REASON FOR THE CALL WAS THE CALLER STATED THAT SINCE FRIDAY, THEY HAD BEEN GETTING JOLTED BY THE BATTERIES IN THEIR LOWER BACK AND NECK. THE CALLER ADDED THAT THEY WERE ALSO HAVING A SHOCK TYPE WAVE IN THEIR NECK WHERE THE LEAD WAS. THE CALLER STATED THE JOLTING STARTED OVER THE WEEKEND AND WAS PROGRESSING AND GETTING WORSE. THE CALLER NOTED THEY HAD NOT HAD ANY FALLS, INJURIES, OR ACCIDENTS BEFORE THIS BEGAN. THE CALLER TURNED THE STIMULATION COMPLETELY OFF A WHILE AGO TO SEE HOW IT WOULD WORK WITHOUT THE STIMULATION, AND THE STIMULATION WAS STILL OFF. THE CALLER STATED IT WAS LIKE A BURNING SENSATION IN THEIR NECK WHERE THE LEAD WAS. THE ISSUE WAS NOT RESOLVED. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE. THE AGENT SENT AN EMAIL TO REGISTRATION TO UPDATE ADDRESS AND PHONE NUMBER.

  Patient problems: Burning Sensation; Electric Shock

  MAUDE report 21411875 ↗
• InjuryFeb 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP). REP REPORTED THAT THERE WERE NO REPORTED ALLEGATIONS AGAINST THE DEVICE. THE PATIENT (PT) REQUESTED THE BATTERY POCKET TO BE MOVED UP FROM THEIR RIGHT BUTTOCK TO THEIR RIGHT FLANK REGION. THE BATTERY REPLACEMENT AND POCKET REVISION WERE COMPLETED ON(B)(6) 2024. THE LEAD SELECT SHOWED ALL GREEN CONNECTIONS AND LEAD IMPEDANCES SHOWED GREEN. THE ISSUE HAS BEEN RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21354570 ↗
• InjuryNov 22, 2024Electromagnetic Compatibility Problem; Adverse Event Without Identified Device or Use Problem; Electromagnetic Compatibility Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE REASON THE PATIENT HAD TO HAVE THE STIMULATOR REMOVED WAS IT STARTED INTERFERING WITH THE DEFIBRILLATOR THE THEY HAD TO HELP THEIR HEART.

  Patient problems: Chest Pain; Pain

  MAUDE report 20760462 ↗
• MalfunctionNov 12, 2024Energy Output Problem; Inappropriate/Inadequate Shock/Stimulation; Battery Problem; Insufficient Device Problem Information; Energy Output Problem; Inappropriate/Inadequate Shock/Stimulation; Battery Problem; Insufficient Device Problem Information

  ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THAT ONE OF THE LEADS FROM THE BATTERY WAS LOOSE. THE PATIENT WAS UNABLE TO TURN IT UP. THE PLAN WAS TO REPLACE THE SYSTEM AND IT WAS SHUT DOWN CURRENTLY. THE PATIENT NOTED WHEN IT WAS TURNED ON IT FELT LIKE SHOCKING.

  Patient problems: Cramp(s) /Muscle Spasm(s); Electric Shock

  MAUDE report 20668008 ↗
• InjuryOct 31, 2024Inappropriate/Inadequate Shock/Stimulation; Insufficient Device Problem Information; Inappropriate/Inadequate Shock/Stimulation; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). MRI TECH REPORTS THE INS AND LEADS WERE REMOVED ON (B)(6) 2023 BECAUSE THE SYSTEM WAS "NOT WORKING AND ELECTROCUTED HIM ON THE INSIDE." MRI TECH REPORTS A SMALL LEAD FRAGMENT REMAINS IN THE PATIENT.

  Patient problems: Electric Shock

  MAUDE report 20578441 ↗
• MalfunctionOct 4, 2024Energy Output Problem; Insufficient Device Problem Information; Energy Output Problem; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT (PT) WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REASON FOR CALL WAS CALLER STATED THAT THE THERAPY STOPPED WORKING ABOUT A YEAR AFTER IT WAS IMPLANTED. CALLER STATED THAT THEY WENT TO A DOCTOR TO TRY TO RESET THE MONITOR TO SEE IF THAT WOULD HELP AND IT DIDN'T. CALLER STATED WITHIN ONE HOUR IT WENT BACK TO DOING THE SAME THING IT WAS DOING BEFORE. CALLER ADDED THAT IT WAS GOING REALLY HIGH TO THE POINT WHERE THEY COULDN'T TOLERATE IT AND THE PAIN WAS IMMENSE BECAUSE THE MACHINE WAS "MESSED UP AND DOING TOO MUCH".  THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.

  Patient problems: Device Overstimulation of Tissue; Pain

  MAUDE report 20369576 ↗
• MalfunctionSep 18, 2024Migration or Expulsion of Device; Unintended Collision; Migration or Expulsion of Device; Unintended Collision

  INFORMATION WAS RECEIVED FROM A PATIENT (PT) VIA HEALTHCARE PROVIDER (HCP) WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). CALLER IS WANTING TO HAVE A REP MEET WITH PT TO CHECK THEIR SYSTEM. PT REPORTED THAT THEY FELL 3 MONTHS AGO AND FEELS LIKE THEIR LEAD IS LOOSE OR OUT OF PLACE. TECHNICAL SERVICES (TSS) TRANSFERRED CALLER TO NAS TO PAGE REP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20248325 ↗
• MalfunctionSep 13, 2024Impedance Problem; Insufficient Device Problem Information; Impedance Problem; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). CALLER STATED THE OPERATIVE REPORT FROM THE REPLACEMENT SURGERY ON (B)(6) 2021 STATES, "THE IMPEDANCES WERE CHECKED, UNFORTUNATELY A COUPLE OF THE CONTACTS WERE FOUND TO BE ABNORMAL ON ONE OF THE LEADS. THEY TRIED WIPING THE LEAD WITH A WET LAP AND A DRY LAP AND REINSERTING IT WHICH DID NOT RESOLVE THE ISSUE. THEY SWITCHED THE LEAD BETWEEN THE 2 PORTS AND FOUND THAT THE SAME LEAD WAS STILL HAVING IMPEDANCE ISSUES ON A COUPLE CONTACTS INDICATING IT WAS THE LEAD AND NOT THE BATTERY. GIVEN THAT PATIENT WAS DOING WELL WITH HER THERAPY PREVIOUSLY THEY DECIDED TO LEAVE THE 2 LEADS AS THEY WERE NOT ABLE TO REPLACE THE ONE WITH IMPEDANCE ISSUES".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20216773 ↗

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