RestorePRIME™ 37701Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00613994842299), received between Dec 19, 2016 and Feb 17, 2026 — classified as 23 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (7 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 38 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 17, 2026Break; High impedance

  INFORMATION WAS RECEIVED FROM A MANUFACTURER'S REPRESENTATIVE (REP) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REASON FOR CALL WAS THE CALLER INDICATED THAT THEY WERE IN A CASE TO REPLACE THE INS AND THE EXTENSION BROKE. THE CALLER WAS TRYING TO IDENTIFY THE EXTENSION THAT WAS CONNECTED TO THE INS AND HOW IT WAS CONNECTED TO THE 3998 LEAD. THE CALLER REVIEWED X-RAY IMAGING WITH THE MD AND DESCRIBED A SYSTEM THAT INCLUDED A 37082 CONNECTED TO 37081. TSS REVIEWED INFORMATION ABOUT THE POSSIBLE COMPONENTS. TROUBLESHOOTING WAS NOT REQUIRED. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. THE SURGEON WILL ATTEMPT TO ACCESS THE EXTENSION SO THE COMPONENT CAN BE REPLACED. INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT (PT) WITH AN IMPLANTED NEUROSTIMULATOR (INS). IT WAS REPORTED THAT PT WAS SCHEDULED FOR A BATTERY REPLACEMENT FOR NORMAL ERI. HCP CAREFULLY CUT DOWN TO THE BATTERY AND ENSURING NOT TO COME IN CONTACT WITH EXTENSIONS. UPON EXAMINATION, THE EXTENSION THAT WAS CONNECTED TO THE BATTERY WAS OBSERVED TO BE COILED TIGHTLY, IT DID NOT APPEAR TO HAVE WIRES INSIDE. THE HCP REMOVED THE OLD BATTERY A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24364149 ↗
• InjuryAug 9, 2024Electromagnetic Interference; Electromagnetic Interference

  INFORMATION WAS RECEIVED FROM A PATIENT (PT) REGARDING AN IMPLANTABLE NEUROSTIMULATOR. THE REASON FOR CALL WAS PT TRYING TO GET AN MRI BUT THE "GENTLEMAN" TOLD THE PT THE IMPLANT IS NOT MRI SAFE. PT STATED THEY NEED MRI OF THE LOWER BACK BECAUSE THEY HAVE SEVERE BACK PAIN. PT REPORTED THEY HAD TO "SHUT THE THING OFF" FOR AN MRI 3 YEARS AGO AND THE STIMULATION NEVER WORKED AGAIN; PT THEN STATED THEY RECEIVED PAPER WORK THAT THE "UNIT" WAS DEFECTIVE. PT STATED THEY HAVE NOT HAD THE THERAPY ON IN AWHILE AND THEY WERE GOING TO HAVE THE IMPLANT REMOVED. AGENT REVIEWED MRI GUIDELINES AND REDIRECTED TO DOCTOR FOR NEXT STEPS.

  Patient problems: Pain

  MAUDE report 19950413 ↗
• InjuryApr 25, 2024Break; Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information; Break; Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT (PT) WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTROINTESTINAL PELVIC FLOOR, URINARY DYSFUNCTION/SACRAL NERVE STIM, AND FECAL INCONTINENCE. THE REASON FOR CALL WAS TO GET MRI INFORMATION. PATIENT REPORTS THAT THEY HAD THE DEVICE REMOVED BECAUSE IT WASN'T HELPING WITH THEIR INCONTINENCE. PATIENT STATES THAT ONE OF THE METAL LEADS BROKE OFF INSIDE OF THEM AND THEY LEFT IT INSIDE DURING EXPLANT SURGERY. AGENT REVIEWED MRI INFORMATION AND REDIRECTED TO HEALTHCARE PROVIDER (HCP) FOR FURTHER ASSISTANCE. PATIENT STATED THE INS NEVER STOPPED WORKING, BUT NEVER DID WORK. PT MENTIONED THE BATTERY WAS LARGE AND UNCOMFORTABLE IN THEIR BODY BECAUSE THEY WERE ONLY 125LBS.

  Patient problems: Device Embedded In Tissue or Plaque; Discomfort

  MAUDE report 19187975 ↗
• InjuryMar 13, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT (PT) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). THE PT REPORTED THE INS NEVER QUITE WORKED EVER; MAYBE A COUPLE MONTHS AFTER IMPLANT IN 2012 IT BROKE AND WOULD NOT WORK FOR IT DID NOT MAKE CONTACT. SINCE IT BROKE IT WAS NOT WORKING. THEY HAD A LOT OF HEALTH ISSUES WITH CHRONIC PAIN.  IN 2013 THE INS ONLY WORKED FOR A WHILE, THEN IT BROKE THEN THEY LEFT IN THERE DUE TO ISSUE. RECORDS INDICATE THE DEVICE WAS REMOVED IN 2013.

  Patient problems: Insufficient Information; Pain

  MAUDE report 18893543 ↗
• MalfunctionJan 15, 2024Display or Visual Feedback Problem; Failure to Power Up; Operating System Becomes Nonfunctional; Display or Visual Feedback Problem; Failure to Power Up; Operating System Becomes Nonfunctional

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR. IT WAS REPORTED THAT THEIR PROGRAMMER IS BLANK AND UNRESPONSIVE. CALLER STATED THEY HAVE TRIED NEW BATTERIES AND THAT STILL DID NOT RESOLVE. THE CIRCUMSTANCES THAT LED TO THE REPORTED ISSUE WERE ASKED BUT UNKNOWN. AGENT HAD CALLER REMOVE BATTERIES AND TRY STRETCHING SPRINGS. CALLER CONFIRMED REGULAR ALKALINE BATTERIES. CALLER REINSERTED AND STILL NOTHING WILL POWER UP ON THE SCREEN OF THE PROGRAMMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18510648 ↗
• MalfunctionJan 15, 2024Failure to Power Up; Failure to Power Up

  INFORMATION WAS RECEIVED FROM A PATIENT REGARDING AN EXTERNAL DEVICE TO AN IMPLANTABLE NEUROSTIMULATOR IMPLANTED FOR SPINAL PAIN INDICATIONS. IT WAS REPORTED THAT YESTERDAY WHEN PT WENT FOR AN MRI THEY FOUND THE CONTROLLER WOULDN'T POWER ON. THEY PUT NEW BATTERIES IN AND IT STILL WOULDN'T COME ON. THEY TESTED THE BATTERIES AND THEY ARE GOOD SO ISSUE IS CONTROLLER. PT MENTIONED THEY HAVEN'T USED CONTROLLER "IN AWHILE BECAUSE I DON'T KNOW IF IT'S ON OR NOT, THE REP CHECKED IT IN THE OFFICE AND I TOLD HIM I DON'T FEEL ANYTHING BUT HE SAID ITS BECAUSE ITS PROGRAMMED THAT WAY SO I AM NOT SUPPOSED TO FEEL IT". PT DIDN'T ALLEGE ANY THERAPY PROBLEMS, BUT SAYS THEY WANTED TO USE CONTROLLER TO SEE IF STIM IS ON OR OFF. WHEN PT GETS NEW CONTROLLER THEY WILL CALL PATIENT SERVICES BACK FOR HELP ON USING PP TO CHECK INS STATUS. NO SYMPTOMS WERE REPORTED. A REPLACEMENT PATIENT PROGRAMMER WAS SENT OUT.(B)(6)2023 RTG0406149 (CON): PT CALLED BACK STATING THEY GOT THEIR PROGRAMMER AND NEEDED HELP. PSS WALKED PT THROUGH USING PROGRAMMER WITH AND WITHOUT ANTENNA PT WAS SEEING NORMAL THERAPY SCREEN WITH LIGHTNING BOLT IN THE TOP LEFT. PSS REVIEWED INS IS ON AND RUNNING. PSS REVIEWED ICONS OF LOW BATTER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18510599 ↗
• InjuryAug 1, 2022Inappropriate/Inadequate Shock/Stimulation; Human-Device Interface Problem; Positioning Problem; Inappropriate/Inadequate Shock/Stimulation; Human-Device Interface Problem; Positioning Problem

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTROINTESTINAL/ PELVIC FLOOR. IT WAS REPORTED THAT THE PATIENT CALLED BECAUSE SHE HAD SURGERY YESTERDAY TO REPLACE THE BATTERY HOWEVER SAID THAT WHEN THE SURGEON OPENED UP THE SITE, THEY WEREN'T FAMILIAR WITH THE PRODUCT: SAID THAT THERE WERE TWO LEADS SO THE PROCEDURE WAS ABORTED. PATIENT SAID THAT THE REPRESENTATIVE (REP) SAID THAT HE WASN'T FAMILIAR WITH THE PRODUCT EITHER. PATIENT SERVICES REVIEWED DEVICE INFORMATION AND EXPLAINED THAT THE COMPONENTS (INS AND EXTENSION) IMPLANTED ARE FROM A DIFFERENT LINE OF THERAPIES WHEREAS THE LEAD IS FOR INTERSTIM. PATIENT SAID THAT THE PROCEDURE WAS POSTPONED FOUR TIMES, TWICE AS PATIENT WAS SICK (UNRELATED) AND THEN ONCE BY THE REP AND THEN HEALTHCARE PROFESSIONAL (HCP). PATIENT STATED THAT AFTER THE LAST ATTEMPTED SURGERY EXPLAINED BELOW THE PATIENT DID NOT HAVE BLADDER CONTROL FOR 2 DAYS.

  Patient problems: Electric Shock; Incontinence; Insufficient Information

  MAUDE report 15140709 ↗
• MalfunctionMar 9, 2022Insufficient 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) FOR URINARY DYSFUNCTION/SACRAL NERVE STIM AND GASTROINTESTINAL/PELVIC FLOOR THERAPY. IT WAS REPORTED THAT THE HCP STATED PATIENT WANTED INS CHECKED AS IT HASN'T BEEN CHECKED IN A WHILE SO THEY AREN'T SURE IF IT'S STILL FUNCTIONING. NO FURTHER COMPLICATIONS WERE REPORTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13703057 ↗
• InjuryJan 24, 2022High impedance; Battery Problem; High impedance; Battery Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE BATTERY WAS AT END OF LIFE BUT THE LEADS HAD HIGH IMPEDANCES. PATIENT WANTED TO BE MRI CAPABLE. A NEW PADDLE WAS PUT IN WITH NO EXTENSIONS OR ADAPTORS AND THE PATIENT HAD A COMPLETE SYSTEM REPLACEMENT. THE ISSUE WAS RESOLVED AT THE TIME OF REPORT. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13334736 ↗
• InjuryAug 30, 2021Insufficient 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) FOR URINARY DYSFUNCTION/SACRAL NERVE STIM AND GASTROINTESTINAL/ PELVIC FLOOR. THE CALLER STATES THE PT HAD A REVISION AT SOME POINT AND, PER THE CALLER'S UNDERSTANDING, THE REVISION OCCURRED BECAUSE THE PT'S 'HANDHELD WASN'T WORKING'. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12387974 ↗
• MalfunctionAug 25, 2021Energy Output Problem; Battery Problem; Energy Output Problem; Battery Problem

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR FAILED BACK SURGERY SYNDROME AND SPINAL PAIN. THE REASON FOR CALL WAS YESTERDAY THE PT GOT THE MESSAGE POWER ON RESET (POR) ON THEIR PROGRAMMER AND THEIR STIMULATION COULD NOT BE ADJUSTED. PATIENT SERVICES REDIRECTED CALLER TO THEIR HCP FOR FURTHER ASSISTANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12367902 ↗
• MalfunctionMar 17, 2021Overheating of Device; Insufficient Device Problem Information; Overheating of Device; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT AND IT WAS REPORTED THAT THE HCP RAN BLOOD TESTS AND AFTER THREE DAYS CALLED THE PATIENT AND PUT THEM ON ANTIBIOTICS. THERE WAS NO INFECTION THIS TIME. AT THE MOMENT THEY FEEL BETTER BUT WOULD STILL LIKE TO MEET WITH A REP.

  Patient problems: Burning Sensation; Discomfort; Insufficient Information; Pain

  MAUDE report 11509394 ↗
• InjuryMar 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTROINTESTINAL/ PELVIC FLOOR. PATIENT STATED LONG TIME AGO "4YRS AGO" BUT SHE IS NOT SURE SHE HAD AN INFECTION NEAR THE IMPLANT AREA AND THEY TREATED HER AT THE HOSPITAL, AND THAT IS WHY HER DOCTOR WANTS THE IMPLANT TO BE CHECKED.

  Patient problems: Unspecified Infection

  MAUDE report 11395986 ↗
• InjuryApr 21, 2020Therapy Delivered to Incorrect Body Area; Therapy Delivered to Incorrect Body Area

  INFORMATION WAS RECEIVED FROM A PATIENT REGARDING THEIR IMPLANTABLE NEUROSTIMULATOR (INS). INFORMATION WAS REPORTED THAT THE PATIENT STATED THE DEVICE THAT WAS PLACED IN 2014 ((B)(4)) DID NOT HELP WITH FECAL INCONTINENCE. THE PATIENT STATED IS ALSO GAVE HER PAIN IN PELVIC REGION. THE PATIENT WENT TO HER HEALTHCARE PROVIDER (HCP) MULTIPLE TIMES FOR REPROGRAMMING WITH HCP STAFF AND MANUFACTURER REPRESENTATIVES (REPS). THE PATIENT STATED THE REP ALSO CALLED PATS FOR ASSISTANCE. THE PATIENT STATED SHE WOULD NOT FEEL STIMULATION IN THE CORRECT AREA. THE PATIENT STATED SHE HAD SURGERY THREE TIMES TO REPOSITION THE LEADS IN 2014, 2015, AND 2016. THE PATIENT WAS IMPLANTED WITH ANOTHER INS, BUT STATED SHE HAD IT REMOVED. THE PATIENT ALSO NOTED HAVING RECONSTRUCTIVE SURGERY ON HER PUDENDAL NERVE. THE PATIENT STATED THE LEADS ARE PLACED CORRECTLY, BUT THE SENSATION IS NOT GOING TO WHERE IT WAS SUPPOSED TO BE GOING. THE PATIENT STATED THE HCP RETIRED AND SHE IS PROBABLY GOING TO SEE A DOCTOR. ADDITIONAL INFORMATION WAS REPORTED THAT SINCE THE DOCTOR PERFORMED PROCEDURES AND USED THE LEADS IN AN OFF LABEL MANNER THE MANUFACTURER REPRESENTATIVE (REP) WAS NOT ABLE TO PROVIDE TECHNICAL ASSISTANCE

  Patient problems: Incontinence; Pain; Undesired Nerve Stimulation

  MAUDE report 9981488 ↗
• InjuryNov 15, 2019High impedance; High impedance

  INFORMATION WAS RECEIVED FROM A MANUFACTURER'S REPRESENTATIVE (REP) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR THE TREATMENT OF RADICULOPATHY AND SPINAL PAIN. IT WAS REPORTED THAT PATIENT HAS AN IMPEDANCE ISSUE. IT WAS REPORTED THAT THE CONTACT 7 8 9 10 11 12 AND 15 ARE ALL OVER 3600 OHMS. IT WAS REVIEWED THAT OVER 3600 OHMS MAY INDICATE THAT AN OPEN CIRCUIT. THE REP ATTEMPTED TO REPROGRAM AROUND THESE ELECTRODES, BUT THE PATIENT PREFERRED THEIR INITIAL SETTINGS, SO THE CALLER WOULD RETURN TO THE INITIAL SETTINGS. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED. NO SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP. IT WAS REPORTED THAT THERE WAS A REPLACEMENT WHICH WAS BELIEVED TO BE DUE TO NORMAL BATTERY DEPLETION. THE HCP DECIDED TO DO A FULL SYSTEM REPLACEMENT BECAUSE A LEAD WAS POSSIBLY FRACTURED. REPLACEMENT WAS DONE IN 2018 HOWEVER ISSUE FOUND IN 2017. THE REP THEN CONFIRMED THAT THE REASON FOR REPLACEMENT WAS ACTUALLY DUE TO THE INITIAL COMPLAINT OF IMPEDANCE ISSUES AND NOT LEAD FRACTURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9331047 ↗
• InjuryAug 15, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR. IT WAS REPORTED THAT THE PHYSICIAN WAS MOVING THE PATIENT¿S DEVICE SYSTEM. THERE WERE NO FURTHER COMPLICATIONS REPORTED OR ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8896341 ↗
• InjuryApr 1, 2019Battery Problem; Battery Problem

  ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT THE PHYSICIAN THOUGHT THAT SCAR TISSUE WAS PROVIDING THE POCKET DISCOMFORT. THE ERI IS FROM NORMAL USE. THE PATIENT WILL BE SCHEDULED TO HAVE THE DEVICE REPLACED AND POSSIBLY RELOCATED BY THE PHYSICIAN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Discomfort; Pain; Scar Tissue; Tingling

  MAUDE report 8471061 ↗
• MalfunctionMar 20, 2019Intermittent Continuity; Intermittent Continuity

  INFORMATION WAS RECEIVED FROM A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR THE TREATMENT OF NON-MALIGNANT PAIN, SPINAL STENOSIS, AND RADICULAR PAIN SYNDROME (RADICULOPATHIES). IT WAS REPORTED THAT THE PATIENT WAS TRYING TO TURN THEIR INS OFF FOR AN MRI BUT THEY ONLY GOT POOR COMMUNICATION. THE PATIENT STATED THEY STILL FEEL THEIR STIMULATION ON MOST OF THE TIME BUT SOMETIMES DID NOT FEEL ANYTHING AT ALL. THE PATIENT PROGRAMMER (PP) HAD POOR COMMUNICATION WITH AND WITHOUT THE ANTENNA. A REPLACEMENT PP WAS SENT. ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) WHO STATED THE PATIENT RECEIVED THE PP BUT WERE NOT ABLE TO PUT THE INS IN MRI MODE. IT WAS REVIEWED THAT THE PATIENT¿S INS DID NOT HAVE MRI MODE. IT WAS REVIEWED HOW TO TURN THE INS ON AND OFF. IT WAS CONFIRMED THAT THE PP WAS SUCCESSFULLY COMMUNICATING WITH THE INS. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Therapeutic Effects, Unexpected

  MAUDE report 8436906 ↗
• InjuryFeb 4, 2019Battery Problem; Battery Problem

  INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR LUMBAR RADICULOPATHY AND SPINAL PAIN. IT WAS REPORTED THAT THE PATIENT RARELY USED THEIR THERAPY BECAUSE IT HAD NOT BEEN HELPFUL. THEY STATED THAT THE IMPLANT BOTHERS THEM MORE THAN IT HELPS. THE PATIENT WAS DIRECTED TO CONSULT WITH THEIR DOCTOR ABOUT HAVING THEIR INS TAKEN OUT. AN ELECTIVE REPLACEMENT INDICATOR MESSAGE WAS REPORTED BUT THERE WERE NO ALLEGATIONS/DISSATISFACTION WITH THE INS LONGEVITY. NO FURTHER COMPLICATIONS REPORTED. ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT REPORTED THAT THE INS WAS REMOVED BUT THE LEAD WAS LEFT IMPLANTED. COMPATIBILITY GUIDELINES WERE PROVIDED THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Discomfort; Therapeutic Effects, Unexpected

  MAUDE report 8301683 ↗
• MalfunctionDec 7, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM THE PATIENT WITH AN IMPLANTABLE NEURO STIMULATOR (INS) FOR SPINAL PAIN. IT WAS REPORTED THAT THE PATIENT HAS A PROBLEM WITH THE BATTERY. PATIENT STATED THAT HE FEELS SO MUCH PAIN ON THE LEFT SIDE. PATIENT IS WORRIED BECAUSE SOMETIMES IT FEELS LIKE HOT CHILI LIKE SOMETHING WAS WRONG. 3 WEEKS AGO THEY STARTED FEELING PAIN IN THEIR HIP. PATIENT SAW THE HCP WHO SENT PATIENT TO PHYSICAL THERAPY. PATIENT SATED THAT THE PHYSICAL THERAPIST TOLD PATIENT THAT THE PAIN IS BECAUSE OF THE WIRES AND THE BATTERY THERE BOTHERING THE MUSCLES. PATIENT STATED THAT THE HCP SAID THEY COULD CHANGE IT TO ANOTHER PLACE IN THEIR STOMACH BUT WOULD LIKE TO TAKE IT OFF BUT STILL HAVE POWER. CLARIFIED STATEMENT PATIENT CONFIRMED HE WAS TRYING TO ASK IF HE CAN LEAVE DEVICES IN BODY OR IF HE NEEDS TO MOVE THEM. PATIENT DIRECTED TO HEALTH CARE PROFESSIONAL (HCP). NO FURTHER PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED IN THIS EVENT.

  Patient problems: Complaint, Ill-Defined; Discomfort; Pain

  MAUDE report 8143787 ↗
• InjuryNov 5, 2018Overheating of Device; Malposition of Device; Overheating of Device; Malposition of Device

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR URINARY DYSFUNCTION/SACRAL NERVE STIM AND GASTROINTESTINAL/ PELVIC FLOOR. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A -BURNING AND STINGING AT THE IMPLANTABLE NEUROSTIMULATOR (INS) SITE SINCE MID (B)(6) 2018. THE PATIENT NOTED THAT IT WENT AWAY AFTER A SHORT TIME, BUT THE SENSATIONS RETURNED ON (B)(6) 2018 AND IT SEEMED WORSE THAN BEFORE. THE BURNING AND STINGING CONTINUED EVEN WHEN THE INS WAS TURNED OFF. THERE WERE NO REPORTS OF TRAUMA OR FALLS THAT COULD BE RELATED TO THIS ISSUE. IN THE END, THE PATIENT WAS RE-DIRECTED TO THEIR HEALTHCARE PROFESSIONAL (HCP) BUT THE PATIENT DIDN¿T HAVE ONE THAT TAKES THEIR INSURANCE. THERE WERE NO FURTHER COMPLICATIONS REPORTED OR ANTICIPATED.

  Patient problems: Burning Sensation; Discomfort; Therapeutic Response, Decreased; Tingling

  MAUDE report 8038807 ↗
• MalfunctionOct 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A HEALTH CARE PROFESSIONAL REGARDING A PATIENT IMPLANTED WITH A NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR. IT WAS REPORTED THAT THE PATIENT HAD THEIR INS AND LEAD REMOVED WITH ONE PARTIAL LEAD REMAINING. THERE WERE NO FURTHER SYMPTOMS OR COMPLICATIONS REPORTED OR ANTICIPATED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7986357 ↗
• MalfunctionOct 10, 2018Failure to Deliver Energy; Battery Problem; Failure to Deliver Energy; Battery Problem

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR NON-MALIGNANT PAIN AND CHRONIC LOW BACK PAIN. IT WAS REPORTED THAT THE PATIENT¿S DEVICE WAS NOT WORKING AND THE ELECTIVE REPLACEMENT INDICATOR (ERI) MESSAGE APPEARED ON THE PATIENT PROGRAMMER (PP) ON THE DAY OF THE REPORT ON A NON-RECHARGEABLE IMPLANTABLE NEUROSTIMULATOR (INS). THE PATIENT ALSO REPORTED THAT SHE HAD A RETURN OF PAIN ON THE DAY PRIOR TO THE REPORT, SO THEY WANTED TO TURN THE STIMULATION BACK ON. THIS WAS WHEN SHE SAW THE ERI MESSAGE. THE PATIENT WAS ABLE TO BYPASS THE ERI MESSAGE AND TURN THE THERAPY BACK ON AGAIN; THIS HELPED REDUCE THE PATIENT¿S PAIN, BUT THEY COULD NOT FEEL THE STIMULATION SENSATION. THE PP SHOWED THAT THE PATIENT HAD ACCESS TO ONE GROUP AND ONE PROGRAM; THE AMPLITUDE WAS AT 10.5 V. IN THE END, THE PATIENT WAS DIRECTED TO THEIR HEALTHCARE PROFESSIONAL (HCP) TO DISCUSS THE THERAPY CONCERNS, ERI AND TO DISCUSS DEVICE REPLACEMENT. ADDITIONAL INFORMATION WAS OBTAINED ON 2018-OCT-09. IT WAS REPORTED THAT POSSIBLE FACTORS THAT COULD HAVE LED TO THE LOSS OF STIMULATION WOULD BE THAT THEY HAD BEEN BLACKING OUT FOR NEARLY A YEAR. WHEN THEY WOULD BLACK OUT THEY WOULD JUST

  Patient problems: Pain; Therapeutic Effects, Unexpected; Therapeutic Response, Decreased

  MAUDE report 7951679 ↗
• InjuryOct 4, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR. IT WAS REPORTED THAT THE PATIENT'S LEADS WERE OUT OF PLACE AND NOT CONNECTED AND THAT THE WEREN'T RECEIVING THERAPY SINCE ABOUT 2 YEARS AGO. THE PATIENT WAS WORKING WITH THEIR DOCTOR TO HAVE THEIR INS AND LEADS REPLACED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Therapeutic Effects, Unexpected

  MAUDE report 7935864 ↗
• InjuryAug 27, 2018Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem

  (B)(4) (HCP, REP): INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR SPINAL PAIN. IT WAS REPORTED THAT THE PATIENT SCRATCHED HIS FACE ON THE DAY OF THE REPORT AND THE DISTAL END OF THE LEAD PULLED OUT OF HIS HEAD; THE LEAD HAD BEEN IMPLANTED SUBCUTANEOUSLY. THE HCP EXPLANTED THE DISTAL 10 CM OF THE LEAD, BUT THE REMAINING PORTION OF THE LEAD AND THE OTHER LEADS REMAINED IMPLANTED; THE PARTIALLY EXPLANTED LEAD WAS OUT OF SERVICE. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT AND THE PATIENT DID NOT WISH TO REVISE THE LEAD BECAUSE HE HAD NOT USED THE IMPLANTABLE NEUROSTIMULATOR (INS) IN FOUR YEARS AND DID NOT PLAN TO USE IT IN THE FUTURE. SURGICAL INTERVENTION DID NOT OCCUR, AND IT WAS NOT PLANNED. THERE WERE NO FURTHER COMPLICATIONS REPORTED OR ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7817339 ↗

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