PrimeADVANCED™ 37702Recalls & reported problems

Summary

The FDA's MAUDE database contains 451 adverse event reports that list this exact device (DI 00613994842312), received between Nov 11, 2015 and Sep 15, 2026 — classified as 193 injuries, 258 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (103 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 451 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  Information was received from a patient who was implanted with an implantable neurostimulator (INS). It was reported that the patient's INS was causing the patient pain, and this was why the patient had to have stem cell therapy performed in 2017.

  Patient problems: Pain

  MAUDE report 50772397 ↗
• MalfunctionJan 5, 2026Migration or Expulsion of Device

  PER CALLER, HER GRANDMOTHER HAS A SPINAL CORD STIMULATOR SYSTEM AND IS CURRENTLY IN HOSPICE CARE. AS OF LAST SATURDAY (B)(6), THE PATIENT'S (PT) INS CAME OUT OF THE INS POCKET BECAUSE THE INS HAD ERODED THROUGH THE SKIN DUE THE GRANDMOTHER'S DECLINING HEALTH. CALLER WORKS WITH AN HCP WHO IS WILLING TO WRITE AN ORDER TO HAVE THE LEADS CUT BY A NURSE SO THAT THE WOUND CAN BE DRESSED PROPERLY BUT THE HCP IS LOOKING FOR THE MANUFACTURER TO APPROVE OF THIS ORDER. TSS REVIEWED THAT THE MANUFACTURER DOESN'T HAVE ANY MEDICAL STANDING OR RESOURCES TO PROVIDE AND THAT CALLER WILL NEED TO DEPEND ON THE NURSING OR OTHER STAFF AVAILABLE TO HER TO ADDRESS THE INS POCKET WOUND AND THE CONCERNS ABOUT INFECTION THAT THE CALLER HAD. CALLER WILL TRY TO CONTACT A WOUND CARE SPECIALIST TO SEE IF THEY CAN ASSIST WITH THE SITUATION AS WELL. THE CALLER MENTIONED THAT THE PT'S INS POCKET WOUND HAD BEEN OPEN FOR A WHILE BUT WHEN ASKED, NEVER OFFERED A TIMEFRAME FOR WHAT THAT MEANT.

  Patient problems: Pocket Erosion; Unspecified Tissue Injury

  MAUDE report 23963861 ↗
• InjuryAug 7, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REASON FOR CALL WAS PATIENT REPORTED THEIR PREVIOUS IMPLANT WASN'T WORKING THAT WELL SO THEY PUT IN A NEW ONE. PATIENT DID NOT RECALL THE REASON WHY THE PREVIOUS IMPLANT WAS NOT WORKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22738535 ↗
• MalfunctionJul 2, 2025Intermittent Continuity; Failure to Deliver Energy; Energy Output Problem; Insufficient Device Problem Information; Intermittent Continuity; Failure to Deliver Energy; Energy Output Problem; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REASON FOR CALL WAS PATIENT REPORTED THAT THE STIMULATION WAS ON BUT WAS NOT DOING ANYTHING FOR THEM. PATIENT STATED THERE WAS A SPIKE IN THE STIMULATION THAT SHOWED THAT IT WAS SUPPOSED TO BE WORKING BUT IT WAS NOT. PATIENT COMMENTED ONE OF THE WIRE WAS OFF ALREADY, SOMEONE CAME TO THEIR HEALTH CARE PROVIDER'S OFFICE TO MAKE AN ADJUSTMENT SO THEY CAN FEEL THE STIMULATION. PATIENT SAID THAT NOW THE STIMULATION WASN'T WORKING AT ALL AND IT WAS SHOWING ON THEIR HAND CONTROL THAT IT SHOULD BE FIRING UP. AGENT ASKED THE PATIENT WHEN THE ISSUE STARTED AND PATIENT SAID THAT THEY TOLD THE GUY THAT WAS OUT LAST TIME THAT THEY USED THE STIMULATION SPARINGLY BECAUSE THEY DIDN'T WANT TO HAVE ANOTHER SURGERY TO GET ANOTHER ONE PUT IN BUT NOW SOMETHING WAS WRONG. PATIENT DENIED ANY RECENT FALLS/TRAUMA. AGENT INSTRUCTED PATIENT TO INCREASE STIMULATION, PATIENT WAS ABLE TO INCREASE STIMULATION BUT MENTIONED THEY CAN'T FEEL THE STIMULATION. AGENT REVIEWED ROLE OF M ANUFACTURER REPRESENTATIVE (REP) AND PROVIDED PATIENT WITH THE NATIONAL ANSWERING SERVICE NUMBER FOR HCP TO USE. THE ISSUE WAS NOT RESOLVED. THE

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

  MAUDE report 22391194 ↗
• InjuryMar 17, 2025Failure to Deliver Energy; Migration or Expulsion of Device; Energy Output Problem; Battery Problem; Failure to Deliver Energy; Migration or Expulsion of Device; Energy Output Problem; Battery Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM A PATIENT. LEAD MIGRATION WAS REPORTED. THE BATTERY WAS DEPLETED, AND THERE WAS ZERO STIMULATION. THE PATIENT HAD AN X-RAY OF THE LEAD WIRES. THE INTERNAL NONRECHARGEABLE IMPLANT BATTERY AND SYSTEM WERE DEAD. THE ISSUE WAS NOT RESOLVED. A SYSTEM REPLACEMENT WAS PLANNED.

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

  MAUDE report 21621275 ↗
• MalfunctionFeb 10, 2025High impedance; High impedance

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THE INS WAS BEING REPLACED FOR ERI HOWEVER ELECTRODE 2 >40000 DURING ROUTINE IMPEDANCE CHECK PRIOR TO REPLACEMENT. REPROGRAMMING WAS DONE; ISSUE IS ON GOING. STIMULATION < (>&<)> PARESTHESIA COVERAGE FEELS THE SAME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21349239 ↗
• InjuryJan 28, 2025Communication or Transmission Problem; Communication or Transmission Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THE PATIENT HAD COMMUNICATION ISSUES AND WEREN'T ABLE TO GET AN MRI. SYSTEM WAS REPLACED. ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21254399 ↗
• MalfunctionJan 23, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REASON FOR CALL WAS TO GET MRI INFORMATION. THE CALLER INDICATED THAT THE PATIENT'S INS IS NOT FUNCTIONING. THE CALLER HAD A NOTE THAT SAID THE PATIENT'S DAUGHTER REPORTED THAT THE INS HAS NOT FUNCTIONED FOR MANY YEARS, THEY DON'T KNOW THE BRAND OF THE IMPLANT, AND THE PATIENT HAD AN MRI AT THE VA SIX MONTHS AGO. THE CALLER DID NOT HAVE OTHER DETAILS ABOUT THE STATUS OF THE IMPLANT. TROUBLESHOOTING WAS NOT REQUIRED. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21218172 ↗
• InjuryJan 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A PATIENT VIA HEALTHCARE PROVIDER WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THE PATIENT HAD A HYBRID SYSTEM WITH ANOTHER MANUFACTURERS DEVICES, AND THE PATIENT REPORTED INEFFECTIVE COVERAGE. A POSSIBLE REVISION WAS PLANNED, AND DURING INTRA-OPERATIVE TESTING, THEY WERE ABLE TO ADEQUATELY GET LOW BACK AND RIGHT LEG PAIN COVERAGE, WHICH WAS PATIENT'S PRIMARY COMPLAINTS. FLUOROSCOPY SHOWED NO EVIDENCE OF LEAD MIGRATION. THE HCP ELECTED TO NOT PROCEED FURTHER WITH REVISION THAT APPEARED TO BE FUNCTIONING AFTER ADEQUATE TESTING. INFORMATION INDICATES THE SYSTEM WAS REMOVED INSTEAD.

  Patient problems: Pain

  MAUDE report 21181163 ↗
• MalfunctionDec 30, 2024Failure to Deliver Energy; No Device Output; Electromagnetic Compatibility Problem; Insufficient Device Problem Information; Failure to Deliver Energy; No Device Output; Electromagnetic Compatibility Problem; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT(PT) REGARDING AN IMPLANTABLE NEUROSTIMULATOR. THE REASON FOR CALL WAS CALLER REPORTED THAT THEY HAD A DYE TEST DONE ON THEIR SPINAL CORD OVER A YEAR AGO, AND THEY HAVE NEVER BEEN ABLE TO GET THE STIMULATOR THAT RUNS IN THEIR ARMS TURNED BACK ON. CALLER STATED THEY ARE SEEING A TRIANGLE WITH AN EXCLAMATION MARK AND A CIRCLE WITH AN I ON THE SCREEN WHEN THEY TRY TO CONNECT TO THE IMPLANT. AGENT REVIEWED INS BATTERY LIFE EXPECTANCY. PATIENT REPORTED NO ISSUE WITH THEIR OTHER IMPLANTED NEURO STIMULATOR. AGENT REVIEWED INFORMATION WITH CALLER AND REDIRECTED TO HEALTHCARE PROVIDER TO FURTHER ADDRESS POSSIBLE INS REPLACEMENT/STATUS OF THE INS.

  Patient problems: Insufficient Information

  MAUDE report 21044638 ↗
• InjuryDec 11, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REASON FOR CALL WAS PATIENT STATED THEY HAD THE IMPLANT REMOVED A FEW YEARS AGO BECAUSE IT WAS NOT WORKING FOR THEM. PATIENT NOTED THAT THE STIMULATOR WAS FOR THE LUMBAR AREA AND PARTIALLY UP AND NOT EVEN IN THE CENTER BACK. PATIENT HAD THE DEVICE REMOVED BUT THE LEADS ARE STILL THERE AND THEY NEED AN MRI. AGENT REVIEWED MRI GUIDELINES WITH ABANDONED LEADS. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE. PATIENT HAS AN APPOINTMENT WITH THEIR HIP DOCTOR ON MONDAY. PT STATED THEY HAD THE IMPLANT FOR ABOUT A YEAR AFTER BEFORE THEY NOTED IT WAS NOT HELPING ANY LONGER.

  Patient problems: Insufficient Information

  MAUDE report 20903018 ↗
• InjuryNov 27, 2024Failure to Deliver Energy; Unintended Collision; Insufficient Device Problem Information; Failure to Deliver Energy; Unintended Collision; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP. CAUSE IS UNKNOWN. PATIENT HAS SCHEDULED AN APPOINTMENT WITH SURGEON TO DISCUSS REPLACEMENT OF SPINAL CORD STIMULATOR BATTERY. THE ISSUE HAS NOT BEEN RESOLVED. PATIENT HAS BEEN WAITING FOR APPOINTMENT WITH SURGEON. REP CONFIRMED PATIENT WILL SHARE INFORMATION WITH SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20797102 ↗
• InjuryNov 15, 2024Migration or Expulsion of Device; Battery Problem; Migration or Expulsion of Device; Battery Problem

  INFORMATION WAS RECEIVED FROM A PATIENT (PT) WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). PATIENT MENTIONED THEIR CURRENT INS WAS LOCATED UNDER THEIR RIB CAGE AND IT RUBBED ON THEIR RIBS AND THIS HAD BEEN THE CASE SINCE THE TIME OF IMPLANT. PATIENT WAS SCHEDULED FOR INS REPLACEMENT ON (B)(6) 2024 AS THEIRS HAD BEEN DEAD SINCE DECEMBER 2023. AGENT REVIEWED INFORMATION AND REDIRECTED PATIENT TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20694926 ↗
• MalfunctionNov 4, 2024Failure to Deliver Energy; Failure to Deliver Energy

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). CALLER SAID PT CAME INTO THEIR OFFICE AND SAID THEY NEEDED TO BE REPROGRAMMED; UPON FURTHER INVESTIGATION, PT SAID THEIR THERAPY JUST "WENT OFF" ONE DAY AND PT DID NOT KNOW STATUS OF DEVICE. CALLER REQUESTED SOMEONE INTO OFFICE TO HELP REPROGRAM PATIENT. TECHNICAL SERVICES (TSS) PROVIDED NAS PHONE NUMBER AND REDIRECTED TO MANAGING HCP.

  Patient problems: Insufficient Information

  MAUDE report 20600523 ↗
• MalfunctionJul 18, 2024No Device Output; No Device Output

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR SPINAL PAIN AND FAILED BACK SURGERY SYNDROME. IT WAS REPORTED THAT THEIR STIMULATOR WAS NOT TURNING ON AND THEY WERE IN A LOT OF PAIN IN THEIR LUNGS. PATIENT STATED THAT THE LAST TIME THEY WERE ABLE TO TURN THE STIMULATOR ON WAS ABOUT 4 MONTHS AGO. PATIENT REPORTED THAT THEY WERE NOT SURE WHAT WAS GOING ON AND WHY THE STIMULATOR WOULD NOT TURN ON. PATIENT ADDED THAT THE PAIN WAS FROM NOT BEING ABLE TO TURN THEIR STIMULATOR ON. AGENT VERIFIED THAT THE PATIENT IS REFERRING TO THEIR IMPLANT AND THE STIMULATION. PATIENT STATED THAT THEIR HANDHELD DEVICE STILL TURNED ON BUT THE IMPLANT DID NOT. AGENT REVIEWED IMPLANT LONGEVITY AND THAT THE PATIENT SHOULD FOLLOW UP WITH THEIR DOCTOR.  AGENT OFFERED AND SENT A PHYSICIAN LISTING TO THE PATIENT. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.

  Patient problems: Pain

  MAUDE report 19776189 ↗
• MalfunctionJun 12, 2024Intermittent Continuity; Failure to Deliver Energy; Failure to Interrogate; Communication or Transmission Problem; Intermittent Continuity; Failure to Deliver Energy; Failure to Interrogate; Communication or Transmission Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). POOR COMMUNICATION SCREEN SEEN WHEN TRYING TO SYNC TO THE INS WITH AND WITHOUT THE ANTENNA TODAY. PT CLAIMS TO STILL FEEL STIMULATION BUT REPORTED LAST TIME SHE SAW REP THAT SHE WAS HAVING ISSUES WITH THE INS STAYING ON. LAST TIME PT CHECKED INS WITH PT PGMR WAS ABOUT 6 MONTHS AGO. REVIEWED POTENTIAL THAT INS MAY OR MOST LIKELY BE AT EOS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19521750 ↗
• InjuryMar 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) VIA A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REP REPORTED THAT THEY HAD THE DEVICE EXPLANTED DUE TO A DEVICE SITE INFECTION. THE ISSUE WAS RESOLVED.

  Patient problems: Unspecified Infection

  MAUDE report 18912909 ↗
• InjuryMar 6, 2024Migration or Expulsion of Device; Battery Problem; Migration or Expulsion of Device; Battery Problem

  ON (B)(6) 2023: THE PATIENT (PT) REPORTED THAT THEIR IMPLANTED NEUROSTIMULATOR (INS) ONLY WORKED FOR 4 MONTHS AFTER IMPLANT.  NO SYMPTOMS REPORTED.  PT INQUIRED ABOUT DEVICE REMOVAL.  THE PT WAS REDIRECTED TO THEIR DOCTOR TO DISCUSS NEXT STEPS. ON FEB-09-2024: ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. THEY REPORTED THAT THE DEVICE DID NOT STOP WORKING, ONE OF THE LEADS HAD MOVED FROM THE ORIGINAL IMPLANTED SPOT CAUSING DISCOMFORT SO THEY STOPPED USING THE DEVICE. PATIENT DID NOT MEET WITH THE HEALTHCARE PROVIDER (HCP) BECAUSE THEY HAD TO HAVE THAT LEAD IMPLANTED TWICE SO THEY JUST GAVE UP ON IT ALL TOGETHER.

  Patient problems: Discomfort; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18847474 ↗
• MalfunctionFeb 19, 2024High impedance; Energy Output Problem; Patient Device Interaction Problem; High impedance; Energy Output Problem; Patient Device Interaction Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REASON FOR CALL WAS CALLER INQUIRED ABOUT LONGEVITY CALCULATION WITH THE FOLLOWING SETTINGS: PROGRAM 1 - 0.75V, 180 PW, 35 RATE, 591 OHMS; PROGRAM 2 - 0.75V, 180 PW, 35 RATE, OVER 4K OHMS, 24 HOURS/DAY USAGE. BATTERY VOLTAGE WAS 2.78V. CALLER THEN MENTIONED THAT ELECTRODE IMPEDANCES WERE AROUND 5K-9K OHMS. TSS HAD CALLER CHECK IMPEDANCES AT 3V WHICH CONTINUED TO SHOW HIGH IMPEDANCES AROUND 4K-9K OHMS ON VARIOUS ELECTRODES. TSS HEARD PATIENT MENTION IN THE BACKGROUND DURING IMPEDANCE CHECK THAT IF THEY TURN THEIR HEAD A CERTAIN WAY THERE'S CHANGE IN STIM. CALLER CONFIRMED THAT PATIENT WAS RECEIVING ADEQUATE THERAPY WITH CURRENT PROGRAMMING DESPITE IMPEDANCE ISSUES. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. TSS REVIEWED LONGEVITY ESTIMATE OF "GREATER THAN 10 YEARS" AND THAT HIGH IMPEDANCES ARE CONSERVING BATTERY LIFE. TSS REVIEWED BATTERY CURVE AND THAT INS WILL HIT ERI/EOS SOON BUT WE CAN'T GIVE EXACT ESTIMATE. PATIENT WEIGHT IS 220 POUNDS. TSS REVIEWED CONSIDERATIONS FOR INS REPLACEMENT WHEN 37702 REACHES EOS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18735725 ↗
• MalfunctionFeb 15, 2024High impedance; High impedance

  ON (B)(6) 2021, INFORMATION WAS RECEIVED FROM A PATIENT (PT) VIA MANUFACTURER REPRESENTATIVE (REP) WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT ELECTRODE 2 OVER 10,000. NO PATIENT PROGRAMMING USES THAT ELECTRODE. THE ISSUE WAS RESOLVED. NO SYMPTOMS WERE REPORTED. ON 2021-AUG-03, ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP AND IT WAS REPORTED THAT THE PATIENT WAS RECEIVING EFFECTIVE THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18717332 ↗
• InjuryFeb 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR NON-MALIGNANT PAIN. IT WAS REPORTED THAT THE PREVIOUS INS, WITH POCKET ADAPTER WAS RUBBING INTO THE PATIENT'S ARMPIT TOO MUCH, SO IT WAS REPLACED FOR COMFORT.

  Patient problems: Discomfort

  MAUDE report 18686866 ↗
• MalfunctionJan 31, 2024Corroded; Mechanical Problem; Failure to Power Up; Battery Problem; Corroded; Mechanical Problem; Failure to Power Up; Battery Problem

  IT WAS REPORTED THAT YESTERDAY THE PATIENT NOTICED THE BATTERIES HAD LEAKED INSIDE THE PATIENT PROGRAMMER. THE PATIENT CLEANED THE BATTERY COMPARTMENT AND PUT IN NEW AAA BATTERIES, BUT THEN THEY SAW A 'CONTACT CLINICIAN' SCREEN WITH ERROR CODE 006. THE PATIENT CALLED THEIR DOCTOR TO REPORT THE 006 ERROR CODE, AND THEY TOLD THE PATIENT THAT THE BUTTONS ON THE PATIENT PROGRAMMER COULD HAVE BEEN MESSED UP, AND ADVISED THE PATIENT TO CALL PATIENT SERVICES TO REQUEST A NEW PATIENT PROGRAMMER. TODAY, THE PATIENT STATED THAT THE PATIENT PROGRAMMER WOULD NOT POWER ON AT ALL, EVEN AFTER REPLACING THE AAA BATTERIES AGAIN. AGENT REVIEWED MEANING OF 006 ERROR CODE (STUCK KEY). THE ISSUE WAS NOT RESOLVED. AN EMAIL WAS SENT TO THE REPAIR DEPARTMENT TO REPLACE THE PATIENT PROGRAMMER. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18618892 ↗
• MalfunctionJan 22, 2024Failure to Power Up; Failure to Power Up

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR COMPLEX REG PAIN SYNDROME TYPE I AND SPINAL PAIN INDICATIONS. CALLER (MRI TECH) REPORTED THE PATIENT PROGRAMMER DOES NOT TURN ON. THEY INSERTED NEW AAA BATTERIES AND THAT DID NOT RESOLVE THE ISSUE. PER PATIENT, THE INS IS STILL FUNCTIONING BUT HAS NOT USED THE PROGRAMMER FOR ABOUT 3 YEARS. RECOMMENDED NOT SCANNING PATIENT UNTIL THE INS IS CONFIRMED TO BE OFF (MRI BRAIN). RECOMMENDED PT SEE MANAGING HCP TO HAVE INS CHECKED AND TO CONTACT MDT IF PP NEEDS REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18552996 ↗
• MalfunctionJan 15, 2024Failure to Power Up; Failure to Power Up

  INFORMATION WAS RECEIVED FROM A PATIENT (PT) REGARDING AN EXTERNAL DEVICE. THE REASON FOR CALL WAS THAT THEY INITIALLY THOUGHT THEY HAD LOST THE PROGRAMMER, HOWEVER THEY FOUND THE PROGRAMMER AND THE PROGRAMMER WOULD NOT POWER ON EVEN THOUGH THEY WERE PRESSING THE POWER BUTTON. PT STATED THAT THEY HAD NEVER REPLACED THE BATTERIES IN THE PROGRAMMER, SO IT WAS SUGGESTED THAT THE PT REPLACE THE BATTERIES; PT STATED THAT THE PROGRAMMER STILL DID NOT POWER ON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18515031 ↗
• MalfunctionJan 13, 2024Failure to Power Up; Adverse Event Without Identified Device or Use Problem; Operating System Becomes Nonfunctional; Failure to Power Up; Adverse Event Without Identified Device or Use Problem; Operating System Becomes Nonfunctional

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE PT REPORTED THAT THEIR PATIENT PROGRAMMER (PP) WOULD NOT POWER ON THIS MORNING. PT SAID THE PROGRAMMER WAS WORKING FINE ON FRIDAY BUT THEY WERE GOING TO ADJUST THE VIBRATION TODAY BECAUSE THEIR BACK HAD STARTED GIVING THEM A PROBLEM LAST NIGHT AND WAS STILL BOTHERING THEM THIS MORNING. PT STATED THEY REPLACED THE BATTERIES WITH NEW AAA ALKALINE WITHOUT SUCCESS. PT INSPECTED THE BATTERY COMPARTMENT BUT DID NOT FIND ANY DAMAGE OR CORROSION. THE PP WAS UNRESPONSIVE. THE ISSUE WAS NOT RESOLVED. AN EMAIL WAS SENT TO THE REPAIR DEPARTMENT TO REPLACE THE PP.

  Patient problems: Discomfort; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18509517 ↗

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