N/A 97755Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00613994925985), received between May 14, 2018 and Sep 7, 2023 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (10 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 7, 2023Computer Software Problem; Overheating of Device; Computer Software Problem; Overheating of Device

  INFORMATION WAS RECEIVED FROM A PATIENT (PT) WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR SPINAL PAIN. IT WAS REPORTED THAT THE PATIENT WAS  GETTING A SOFTWARE PROBLEM 1. INTELLIS 2. 3.0 3. 243 4. QF_PORT (SCREEN 99) AND THEIR RTM WAS GETTING HOT WHILE RECHARGING. PT SAID THEY HAD CALLED THEIR PAIN CLINIC REGARDING THIS ISSUE AND SOMEONE HAD BROUGHT THEM A REPLACEMENT CONTROLLER ON FRIDAY (PT WAS NOT SURE IF IT WAS A MDT REP OR NOT). PATIENT SERVICES (PSS) UNABLE TO LOCATE REPLACEMENT RECORD/PREVIOUS CALL. PT SAID THEY TRIED THE REPLACEMENT CONTROLLER AND WAS HAVING THE SAME PROBLEMS, THEREFORE THEY THOUGHT IT WAS THE RTM. AN EMAIL WAS SENT TO THE REPAIR DEPARTMENT TO REPLACE THE DEVICE. WHEN PSS ASKED WHO THEIR MANAGING HCP WAS, PT PROVIDED HCP AND FACILITY INFO. ON (B)(6) 2023 PATIENT REPORTED DIFFICULTY WITH THE RECHARGER GETTING HOT, AND THAT THEY CONTACTED A REP ON 2021-MAY-24. THE REP CONFIRMED THEY PROVIDED A TEMPORARY NEW ANTENNA TO THE PATIENT UNTIL PATIENT WAS PROVIDED A PERMANENT REPLACEMENT. PATIENT CONFIRMED RECEIPT OF THE RECHARGER REPLACEMENT, WHICH RESOLVED THE ISSUE.

  Patient problems: Burning Sensation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17702321 ↗
• MalfunctionAug 17, 2023Failure to Deliver Energy; Failure to Interrogate; Overheating of Device; Battery Problem; Charging Problem; Communication or Transmission Problem; Connection Problem; Insufficient Device Problem Information; Failure to Deliver Energy; Failure to Interrogate; Overheating of Device; Battery Problem; Charging Problem; Communication or Transmission Problem; Connection Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT (PT) REPORTED THEY HAD BEEN HAVING TROUBLE CHARGING THEIR IMPLANT SINCE "LET'S SAY MAY 2ND." PT SAID THEIR CONNECTIVITY WITH INS WAS VERY SENSITIVE; RECHARGE QUALITY WOULD FLUCTUATE BETWEEN EXCELLENT, GOOD, AND POOR, AND DELIVERED CHARGE TO IMPLANT VERY SLOWLY WHILE ALERTING PT TO REPOSITION RECHARGER FREQUENTLY. PT SAID ONE TIME THEY HAD BEEN CHARGING INS STARTING FROM 40%, TRIED CHARGING FOR 2 HOURS AND NEVER INCREMENTED PAST 40%. PT CONFIRMED THEY HAD SEEN SOME OTHER ERROR/ALERT SCREENS WHEN RECHARGING BUT COULDN'T RECALL ALL OF THEM (PT MENTIONED ONE BEING ABOUT BAD CONNECTIVITY). PT REPORTED THEY HAD SEEN PASSIVE RECHARGE SCREENS WHEN THEY TRIED TO BEGIN CHARGING - AGENT REVIEWED WHAT PASSIVE RECHARGE MODE IS. PT SAID THEY TRIED RESETTING CONTROLLER, BUT THAT HADN'T RESOLVED THEIR ISSUE. AGENT HAD PT EXAMINE THE CONTROLLER PORT AND RECHARGER PLUG FOR ANY VISIBLE DAMAGE AT CONNECTION SITES; PT SAID NOTHING APPEARED TO BE WRONG. PT DENIED HEATING OF RECHARGER WHEN TRYING TO CHARGE THEIR IMPLANT. THE ISSUE WAS NOT RESOLVED. AN EMAIL WAS SENT TO THE REPAIR DEPARTMENT TO REPLACE THE RECHARGER (EXCHANGE). PT SAID THEIR IMPLANT DID THEM GREAT JUSTICE

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

  MAUDE report 17564031 ↗
• MalfunctionMay 10, 2023Overheating of Device; Insufficient Device Problem Information; Overheating of Device; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT (PT) REGARDING AN EXTERNAL DEVICE. THE REASON FOR CALL WAS PT SAID THEIR RECHARGER (RTM) STOPPED WORKING, GOT HOT, AND BURNT THEM ON THEIR BACK. PT SAID IT DID LEAVE A MARK BUT WAS GONE NOW. PT SAID IT WAS A 1ST DEGREE BURN BUT SAID THEY WERE NOT WORRIED ABOUT IT. AN EMAIL WAS SENT TO THE REPAIR DEPARTMENT TO REPLACE THE RTM.

  Patient problems: Burning Sensation; Erythema

  MAUDE report 16905100 ↗
• MalfunctionSep 23, 2021Overheating of Device; Connection Problem; Adverse Event Without Identified Device or Use Problem; Overheating of Device; Connection Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A PATIENT (PT) REGARDING AN EXTERNAL DEVICE. THE REASON FOR CALL WAS TODAY THE RECHARGER (RTM) CORD WENT UP IN FLAMES. PT SAID THAT THE RTM CORD BURNT THEIR BACK AND WHEN THE PT TOUCHED THE CORD THEY BURNT THEIR HAND (PT SAID THERE WAS A MARK BUT THE PT WAS NOT WORRIED ABOUT THAT). PT SAID THEY SAW SMOKE COMING FROM THE RTM THEN THEY SAW FLAMES WHEN PICKING UP THE RTM. PT SAID THE RTM WAS NO LONGER WORKING. A REPLACEMENT RTM WAS SENT TO THE PATIENT. PT SAID THAT THEY WILL HAVE A BAD BACK WITHOUT THEIR RTM FOR IT WILL FEEL LIKE 20 SWORDS IN THEIR BACK UNTIL THEY GET THE NEW RTM.

  Patient problems: Burn(s); Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12520165 ↗
• MalfunctionOct 9, 2020Overheating of Device; Inappropriate/Inadequate Shock/Stimulation; Connection Problem; Overheating of Device; Inappropriate/Inadequate Shock/Stimulation; Connection Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM PATIENT WHO REPORTED THAT THE CIRCUMSTANCES THAT LED TO CORD BURNING AND SHOCKING WAS BECAUSE THE DEVICE THAT PATIENT PUT NEXT TO THEIR BACK TO RECHARGE THE IMPLANTED DEVICE HAD LET GO OF THE CHARGE WIRE. PATIENT WAS ASKED IF THE ISSUE WAS RESOLVED AND PATIENT STATED DEFINITELY.

  Patient problems: Burn(s); Pain

  MAUDE report 10658980 ↗
• MalfunctionMar 3, 2020Overheating of Device; Delayed Charge Time; Charging Problem; Overheating of Device; Delayed Charge Time; Charging Problem

  INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE RECHARGER (RTM) WON¿T RECOGNIZE THE INS AND A ¿NO DEVICE FOUND¿ MESSAGE WAS DISPLAYED. THE PATIENT REPORTED THAT THERE WAS DIFFICULTY CHARGING THE INS AND IT TOOK 3 HOURS TO CHARGE TO ABOUT 80%. IT WAS REPORTED THAT THE FIRST INCH OF THE RTM CORD THAT GOES INTO THE PADDLE GETS SO HOT THAT IT BURNT HER SKIN.

  Patient problems: Burn(s)

  MAUDE report 9781556 ↗
• MalfunctionJan 7, 2020Overheating of Device; Overheating of Device

  INFORMATION WAS RECEIVED FROM A PATIENT REGARDING THEIR IMPLANTABLE NEUROSTIMULATOR (INS) FOR NON-MALIGNANT PAIN. INFORMATION WAS REPORTED THAT A COUPLE MONTHS AGO, THE PATIENT'S CONTROLLER BATTERY STARTED DEPLETING MORE QUICKLY TO WHERE THE CONT ROLLER WOULD DEPLETE FROM 100% CHARGE TO 40% CHARGED IN 15 MINUTES. THE PATIENT SAID THIS MORNING HE NOTICED THAT THE CONTROLLER ITSELF WAS GETTING HOT AND SO WAS THE RECHARGE ANTENNA, SO HOT THAT IT BURNT HIS REAR END. THE PATIENT IS BEING SENT NEW EXTERNAL DEVICES. NO FURTHER COMPLICATIONS WERE REPORTED. NO ADDITIONAL PATIENT SYMPTOMS WERE REPORTED.

  Patient problems: Burn(s)

  MAUDE report 9558764 ↗
• MalfunctionAug 23, 2019Material Frayed; Overheating of Device; Charging Problem; Communication or Transmission Problem; Material Frayed; Overheating of Device; Charging Problem; Communication or Transmission Problem

  INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR SPINAL PAIN. IT WAS REPORTED THAT WHEN THE PATIENT WAS CHARGING THE INS THE CONTROLLER SCREEN FLASHED AN "EMERGENCY MESSAGE" AND SAID TO CALL MDT. THE PATIENT STATED THEN THE SCREEN WENT BLANK AND NOW THEY COULDN'T GET THE MESSAGE TO APPEAR AGAIN, BUT THEY HAD RESUMED CHARGING THE INS. IT WAS LATER NOTED THAT THE CONTROLLER DISPLAYED A SOFTWARE PROBLEM MESSAGE. A REPLACEMENT CONTROLLER WAS SENT TO THE PATIENT. THE PATIENT ALSO REPORTED THAT THEY HAD BEEN HAVING DIFFICULTIES CHARGING THE INS BECAUSE THE RECHARGE QUALITY DROPS FROM EXCELLENT TO POOR WITHOUT THEM MOVING. THE PATIENT STATED THAT THIS CAUSED THEM TO CHARGE UP TO 2-3 HOURS A TIME. THE PATIENT ALSO MENTIONED THAT WHEN THE RECHARGING DIFFICULTIES STARTED THEY NOTICED THAT THE RECHARGER (RTM) GOT SO HOT IT "BURNS" THEM AND WAS BURNING THEIR SKIN. THE PATIENT SAID THEY HAD TO PUT A CLOTH BETWEEN THE RTM AND THEIR SKIN. THE RTM CORD WAS FRAYED AT THE ENTRANCE TO THE DOUGHNUT. A REPLACEMENT RTM WAS SENT TO THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: Burn(s)

  MAUDE report 8926554 ↗
• MalfunctionNov 28, 2018Overheating of Device; Overheating of Device

  INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR SPINAL PAIN. IT WAS REPORTED THAT THE PATIENT'S CONTROLLER WAS GETTING HOT DURING THE RECHARGE PROCESS BUT THEY WERE STILL ABLE TO CHARGE SO THEY DIDN'T CALL RIGHT AWAY. NOW THE CONTROLLER WONT CHARGE THE INS AND REMOVING/REINSERTING THE BATTERIES DID NOT RESOLVE THE ISSUE. WHILE TRYING TO CHARGE ON THE DAY OF THE REPORT THE RECHARGER GOT HOT AND THEN THE CONTROLLER GOT HOT AS WELL. THE PATIENT NOTED THAT THEY GOT SO HOT THAT IT ALMOST BURNED A BLISTER ONTO THEM. THE CONTROLLER THEN INDICATED THAT IT NEEDED TO BE CHARGED AND WAS SHOWING THE ORANGE BATTERY LEVEL AND IT WAS NOT FLASHING THE GREEN LIGHT WHEN PLUGGED IN TO INDICATION THAT IT WAS CHARGING. THE CONTROLLER BATTERY HAD DEPLETED EXTREMELY FAST. THE PATIENT COULD HEAR SOMETHING RATTLING AROUND INSIDE THE CONTROLLER WHEN THEY SHOOK IT AND STATED THAT IT HAD FALLEN OFF THEIR BED 'A FEW WEEKS AGO.' THEN THE PATIENT NOTED THAT THE CONTROLLER WAS ABLE TO CHARGE AND WAS ALSO SHOWING THE RED WARNING BATTERY LEVEL FOR THE INS. THE CONTROLLER AND RECHARGER WERE BOTH REPLACED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Burn(s)

  MAUDE report 8111158 ↗
• MalfunctionSep 10, 2018Overheating of Device; Connection Problem; Overheating of Device; Connection Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR (INS) FOR NON-MALIGNANT PAIN. THE REP REPORTED THAT THE PATIENT STATED THAT THE PAD (RECHARGER) WAS CAUSING HER BACK TO FEEL LIKE IT BURNED AND LEAVES A READ MARK. THE PATIENT STATED THAT WHETHER THEY ARE LEANING ON A COUCH OR JUST SITTING UP, SHE WAS GETTING THE RED MARK AND BURNING SENSATION AT INS SITE. TECHNICAL SERVICES SUGGESTED CHANGING THE RECHARGE SPEED TO 3 OR 2. THE PATIENT REPORTED GETTING "TRY AGAIN" ON HER CONTROLLER. THE PATIENT STATED THAT THEY HAD ALSO NOTICED DISCOLORATION OF THE RECHARGER WIRE, WHERE IT GOES INTO THE RECHARGER PAD ITSELF. IT WAS NOTED THAT THE CONTROLLER HAD BEEN REPLACED MULTIPLE TIMES. NO FURTHER COMPLICATIONS WERE ANTICIPATED/REPORTED.

  Patient problems: Burn(s); Burning Sensation; Erythema

  MAUDE report 7859707 ↗
• MalfunctionMay 14, 2018Device Displays Incorrect Message; Battery Problem; Device Displays Incorrect Message; Battery Problem

  MDR DECISION CORRECTED TO NOT REPORTABLE. NO ADDITIONAL SUPPLEMENTAL REQUIRED UNLESS ADDITIONAL INFORMATION RECEIVED INDICATES REPORTABLE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7510216 ↗

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