PrimeAdvanced® SureScan® 97702Recalls & reported problems

Summary

The FDA's MAUDE database contains 2,263 adverse event reports that list this exact device (DI 00643169109513), received between Oct 29, 2014 and Sep 16, 2026 — classified as 1 death, 963 injuries, 1,299 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (455 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 2,263 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 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 did not help their situation and their whole system was removed. They tried to reprogram the device several times after implant, but it did not give the patient any relief.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50791580 ↗
• InjuryJul 30, 2026Break

  Historical information was received from a patient (pt) regarding an implantable neurostimulator (INS). Pt mentioned historical information about their prior INS that was replaced in 2019; Patient reported their old INS's leads and insulation come apart and the wires frayed, so they had to have the system removed and replaced. Agent asked if that issue happened in 2019; patient stated yes, and provided the revision date of (b)(6) 2019. Pt mentioned that their doctor who previously fixed the INS had changed practices and that new practice didn't take the patient's workman's comp that covered their INS and replacements. Agent documented reported information. No symptoms were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50087264 ↗
• InjuryJul 29, 2026Disconnection; Insufficient Device Problem Information

  Information was received from Patient's representative regarding an implantable neurostimulator (INS). The reason for call was caller reported the implantable neurostimulator (INS) was still inside the patient¿s body but was not working and had become disconnected. Caller stated that when they went to do the surgery and replaced the wires, the wires were disconnected because the threading was bad. Agent did their best to accurately document information given. Caller stated that the SCS implant could not be removed because the patient was unable to breathe while on the operating table during the operation. For the event date, caller stated quite a few years. Caller stated that the patient was now using a pain pump.

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50075846 ↗
• MalfunctionJun 22, 2026Migration or Expulsion of Device; Unstable

  INFORMATION WAS RECEIVED FROM A PATIENT (PT) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REASON FOR CALL WAS PATIENT REPORTED THEIR NEUROSTIMULATOR WAS FLIPPING OVER WHEN THEY WERE ROLLING OVER NIGHT AND THEY THINK THE BATTERY WAS PEELING OFF THEIR LEADS. PT SAID THEY WERE IN SO MUCH PAIN, SO THEY WENT TO THE EMERGENCY ROOM SUNDAY NIGHT. PT SAID THEY DON'T KNOW WHO CAN HELP THEM. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.

  Patient problems: Pain

  MAUDE report 25579118 ↗
• MalfunctionMay 15, 2026Migration or Expulsion of Device

  INFORMATION WAS RECEIVED FROM A PATIENT REGARDING AN IMPLANTABLE NEUROSTIMULATOR. IT WAS REPORTED THAT THEY WENT TO GET AN MRI AND THE MRI FACILITY MENTIONED THAT THEY COULDN'T DO THE MRI BECAUSE THERE WAS METAL IN THE STIMULATOR AND THE WIRE WAS LOOSE. PATIENT STATED NOW THEY WERE SITTING IN A REHAB FACILITY AND HAD BEEN IN THE HOSPITAL FOR 4 WEEKS. PATIENT NOTED THEY WERE TIRED OF BEING IN SOME PLACES THAT WERE DRIVING THEM CRAZY. PATIENT ASKED IF THEY NEEDED TO GO BACK TO THE HOSPITAL TO GET THE WIRES TAKEN CARE OF. AGENT EMAILED PATIENT PHYSICIAN LISTINGS. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25182484 ↗
• MalfunctionMay 11, 2026Malposition of Device; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REASON FOR THE CALL WAS THE PATIENT REPORTED THEY SAW THEIR PAIN MANAGEMENT DOCTOR ON THE 5TH AND THE DOCTOR THINKS THAT THEIR STIMULATOR MIGHT NOT BE WORKING AND THAT IT IS LOCATED IN A BAD PLACE ON THEIR BODY. PATIENT REPORTED THAT THE DOCTOR WANTS A REPRESENTATIVE TO MEET WITH THE PATIENT TO CHECK THE INS. PATIENT NOTED THEIR DOCTOR WAS PLANNING TO CALL AS WELL. PATIENT STATED THAT THE INS TOUCHES THEIR SPINE AND PINCHES THEIR NERVES IN THEIR LOWER BACK AND HAS ALWAYS BEEN THIS WAY SINCE IT WAS IMPLANTED IN 2015. PATIENT NOTED THAT THEIR DOCTOR TOLD THEM TO CALL AND PATIENT REPORTED THEY CALLED THE REPRESENTATIVE MULTIPLE TIMES, LEAVING A VOICEMAIL BUT THEY HAVE NOT HEARD BACK. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE. AGENT PROVIDED THE PATIENT WITH THE PHONE NUMBER FOR THEIR DOCTOR TO CALL.

  Patient problems: Discomfort

  MAUDE report 25138171 ↗
• MalfunctionMay 8, 2026Failure to Deliver Energy; Energy Output Problem

  INFORMATION WAS RECEIVED FROM A PATIENT (PT) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REASON FOR CALL WAS PT REPORTED THE STIMULATOR IN THEIR RIGHT SIDE HAS GONE 'DEAD'. PT STATED NORMALLY THEY CAN FEEL THE STIMULATION IN THEIR RIGHT ARM, BUT THEY NOTICED ON TUESDAY MORNING THAT THE STIMULATION WAS NOT WORKING. PT MENTIONED THEY LEFT THE CONTROLLER YESTERDAY HOPING THAT THE STIMULATION WOULD TURN BACK ON AND THEY TRIED TO CHANGE THE BATTERY IN THE CONTROLLER BECAUSE THEY THOUGHT THAT WAS THE PROBLEM. PT ALSO MENTIONED THAT THEY THOUGHT THEY SAW THE DOCTOR SYMBOL ON THEIR CONTROLLER BUT WAS NOT ABLE TO CONFIRM BECAUSE THEY CANNOT FIND THEIR CONTROLLER. AGENT REVIEWED INFORMATION. AGENT PROVIDED NAS PHONE NUMBER AND REDIRECTED PT TO THEIR HEALTHCARE PROVIDER (HCP) TO SET UP AN APPOINTMENT WITH MANUFACTURER REPRESENTATIVE (REP) TO FURTHER ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25124997 ↗
• InjuryMay 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS EVALUATED FOR A POSSIBLE INFECTION AT THE BATTERY POCKET SITE, AND CULTURES FROM THE BATTERY POCKET/SITE WERE SENT. IT WAS FURTHER REPORTED THAT THE FULL IMPLANTED NEUROSTIMULATION SYSTEM WAS REMOVED DUE TO THE SUSPECTED INFECTION AT THE BATTERY SITE. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY, AND THE ISSUE WAS REPORTED AS RESOLVED. THE MANUFACTURER REPRESENTATIVE (REP) INDICATED THEY WOULD SEND ANY FURTHER INFORMATION AS THEY BECOME AWARE.

  Patient problems: Unspecified Infection

  MAUDE report 25123414 ↗
• MalfunctionMay 7, 2026High impedance

  ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE. IT WAS REPORTED THAT THE CAUSE OF THE HIGH IMPEDANCE ISSUE WAS UNKNOWN. THE PATIENT HAD 2 ELECTRODES THAT WERE WORKING AND THEY WERE RECEIVING GOOD RELIEF. AT THIS TIME, THE PATIENT'S INS BATTERY SHOWED THAT IT WASN'T DUE FOR REPLACEMENT; THE REPRESENTATIVE NOTED THAT THE PATIENT'S INSURANCE WOULDN'T REPLACE THE INS AS IT WASN'T DUE FOR REPLACEMENT AND THE PATIENT WAS RECEIVING GOOD RELIEF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25112398 ↗
• InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT (PT) WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). REP REPORTS SYSTEM HAD BEEN EXPLANTED AT AN UNKNOWN EARLIER DATE. REP REPORTS INS SITE WAS FULLY HEALED, THEY BELIEVE REMOVAL SURGERY WAS OVER 1 YEAR AGO. REP REPORTS THE PATIENT REPORTED INSUFFICIENT/LACK OF RELIEF.  REP WAS UNABLE TO CONFIRM IF THE PATIENT NEVER RECEIVED ADEQUATE THERAPY OR IF THE PATIENT HAD A CHANGE IN THEIR THERAPY. LOCATION OF REMOVED SPINAL CORD STIMULATOR WAS UNKNOWN. REP REPORTS THEY WERE NOT PRESENT FOR REMOVAL, AND HAD NO FURTHER DETAILS.

  Patient problems: Insufficient Information

  MAUDE report 25004444 ↗
• InjuryApr 16, 2026High impedance; Therapy Delivered to Incorrect Body Area

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT (PT) WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR NON-MALIGNANT PAIN. IT WAS REPORTED THAT THERE WAS A RETURN OF PAIN. PATIENT HAS WALKING DIFFICULTY, IMMOBILITY, LOSS OF BALANCE, AND IS UNABLE TO GET OUT OF BED. PT HAS CONTINUED INCREASED PAIN. HIGH IMPEDANCE ISSUE WITH 11,12 AND PHYSICIAN NOTE THAT THE LOWER LEAD ONLY HAS 4 ELECTRODES IN THE EPIDURAL SPACE. PHYSICIAN DID DISCUSS POSSIBLE REVISION/REPLACEMENT . PT WILL CONSIDER IT, BUT IS CONCERNED WITH THEIR ADVANCED AGE. THE ISSUE IS ON ONGOING. THE MANUFACTURER REPRESENTATIVE (REP) INDICATED THEY WOULD SEND ANY FURTHER INFORMATION AS THEY BECOME AWARE. ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). THE REP REPORTED THAT THE PAIN WAS A RETURN OF BASELINE PAIN AND THE PHYSICIAN IS AWARE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT THERE WERE HIGH IMPEDANCES, >10000 ON ELECTRODES 11,12,13. STIMULATION WAS REPORTED IN THE INCORRECT LOCATION. TRIED TO PROGRAM AROUND. INS IS ALSO AT ERI. THE ISSUE WAS RESOLVED. THE MANUFACTURER REPRESENTATIVE (REP) INDICA

  Patient problems: Ambulation or Postural Difficulties; Inappropriate Device Stimulation of Tissue; Pain

  MAUDE report 24899012 ↗
• MalfunctionMar 25, 2026Failure to Interrogate; Malposition of Device; Battery Problem; Communication or Transmission Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM A PATIENT (PT). IT WAS REPORTED THAT THEY USED THE DEVICE ALMOST CONTINUOUSLY FOR AS LONG AS THE BATTERY LASTED. THEY REALLY DID NOT SEE THAT IT HELPED AT ALL WHEN THE BATTERY DIED. THEY DID NOT REPLACE IT. ADDITIONAL INFORMATION WAS RECEIVED FROM A PATIENT (PT). IT WAS REPORTED THAT THEY NEVER SAW ANY BENEFIT. THE BATTERY WENT DEAD AND THERE WAS NO REASON TO FIX IT. NO ACTIONS WERE TAKEN/WILL BE TAKEN. THE ISSUE IS NOT RESOLVED AND THEY MAY REMOVE THE DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 24688639 ↗
• MalfunctionMar 19, 2026Premature Discharge of Battery; Break; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM AN MAGNETIC RESONANCE IMAGING (MRI) TECHNICIAN REGARDING A PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS). THE REASON FOR CALL WAS CALLER STATED THAT THE PATIENT (PT) NEEDED AN MRI OF THEIR BACK BECAUSE PT THOUGHT THE INS MALFUNCTIONED. THE CALLER DID NOT HAVE FURTHER INFORMATION AS TO WHAT THE MALFUNCTION WAS. AGENT REVIEWED POSSIBLE END OF SERVICE (EOS) WITH THE CALLER. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FILL OUT MRI ELIGIBILITY FORM IF INS IS EOS. AGENT REVIEWED MRI MODE IF INS IS NOT EOS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24645771 ↗
• InjuryMar 2, 2026Insufficient Device Problem Information

  PATIENT STATED "LAST TIME I TRIED TO TURN IT ON IT WOULDN'T TURN ON". PATIENT STATED THEY PLANNED TO HAVE THE STIMULATOR REMOVED AND INQUIRED ABOUT THE REMOVAL PROCESS. AGENT REVIEWED CONSIDERATIONS AND REDIRECTED TO HEALTHCARE PROVIDER (HCP). NO SYMPTOMS WERE REPORTED. PATIENT REPORTED THE STIMULATOR WAS REMOVED LAST YEAR. PATIENT STATED THE SCS DEVICE DID NOT HELP HER LIKE THEY WOULD HAVE LIKED FOR IT TO AND WANTED THE SCS DEVICE TO BE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24487253 ↗
• MalfunctionFeb 11, 2026Electromagnetic Interference; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT REGARDING AN IMPLANTABLE NEUROSTIMULATOR. THE REASON FOR CALL WAS PATIENT REPORTED THEY HAD AN MRI LAST WEEK AND WAS TOLD BY SOMEONE THAT IT WAS CONTRADICTORY FOR THEM TO HAVE HAD THE MRI DONE. PATIENT SAID THEY WERE TOLD BY THE MEDICAL PROVIDER THAT THE MRI WAS SAFE, BUT THEY WERE THEN TOLD IT WAS NOT. PATIENT MENTIONED THEY HAD NOT PUT THEIR DEVICE INTO MRI MODE IN YEARS BECAUSE THE DEVICE NEVER WORKED FOR THEM. PATIENT ALSO SAID IT WAS PAINFUL IN THE AREA WHERE THE IMPLANT WAS AND IT FELT LIKE FAT GLOBULES WERE GROWING AROUND IT AND IT WAS VERY PAINFUL AND SOMETIMES THEY COULDN'T EVEN LAY ON THAT SIDE. PATIENT WENT TO A NEUROLOGIST OVER A YEAR AGO AND THE NEUROLOGIST SAID IT WOULD BE MORE HARMFUL TO TAKE THE IMPLANT AND LEADS OUT THAN TO LEAVE IT IN. THE MRI LASTED OVER A HALF HOUR AND PATIENT SAID THEIR HEART FELT LIKE IT WAS GOING TO JUMP OUT OF THEIR CHEST DURING THE WHOLE PROCEDURE. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.

  Patient problems: Insufficient Information; Pain

  MAUDE report 24314089 ↗
• InjuryJan 15, 2026Insufficient Device Problem Information

  PATIENT MENTIONED THAT THEIR IMPLANTABLE NEUROSTIMULATOR (INS) WAS REPLACED BECAUSE THE LEAD WAS 'MESSED UP'.

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

  MAUDE report 24083022 ↗
• InjuryJan 9, 2026Break; Failure to Deliver Energy; Environmental Compatibility Problem; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. THE PATIENT STATED THEIR STIMULATOR WORKED FINE, THEN THEY RECEIVED A SHOT. THEY WENT TO USE THEIR UNIT, AND IT DIDN'T WORK. THE PATIENT HAD BEEN GETTING SHOTS FOR THE PAST COUPLE MONTHS FOR BACK PAIN.

  Patient problems: Insufficient Information

  MAUDE report 24028987 ↗
• InjuryDec 29, 2025No Device Output; No Device Output

  THE REASON FOR CALL WAS CALLER STATED THEY WERE TOLD TO CALL AND RECEIVE IMPLANT REPORTS BECAUSE THEY ARE HAVING THE IMPLANT REMOVED. PATIENT REPORTED THEY MET WITH A MANUFACTURING REPRESENTATIVE (REP) 12YRS AGO AND HAD PROGRAMMING DONE AND THE DEVICE HAS NEVER BEEN ABLE TO TURN ON. AGENT REVIEWED IMPLANT SHEET. AGENT WARM TRANSFER PATIENT TO PRS FOR IMPLANT SHEET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23906466 ↗
• InjuryDec 18, 2025Battery Problem; Communication or Transmission Problem; Insufficient Device Problem Information; Battery Problem; Communication or Transmission Problem; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT (PT) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REASON FOR CALL WAS PATIENT SAID THAT THEY WERE SEEING A SCREEN A FEW WEEKS AGO BUT CAN'T REMEMBER WHAT IT SAID. TRIED TO GET PT TO DESCRIBE THE SCREEN, BUT THEY WERE VERY UNRESPONSIVE AND HAD TROUBLE ANSWERING QUESTIONS. EVENTUALLY DURING THE CALL, PT SAID THEY ARE NOW SEEING A POOR COMMUNICATION SCREEN. BASED ON THE AGE OF THE INS, ADVISED THAT PT FOLLOW UP WITH HCP/REP. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT STATING THEY NEED A NEW INNER BATTERY AND THEY HAVE AN APPOINTMENT FOR THAT NEW BATTERY ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23840037 ↗
• InjuryDec 17, 2025Electromagnetic Interference; Overheating of Device; Electromagnetic Interference; Overheating of Device

  ADDITIONAL INFORMATION FROM THE MANUFACTURING REPRESENTATIVE (REP) INDICATED THAT THE INS AND LEAD WERE EXPLANTED ON (B)(6) 2025. THE DEVICE WILL BE RETURNED.

  Patient problems: Burning Sensation

  MAUDE report 23830466 ↗
• InjuryDec 17, 2025Premature Discharge of Battery; Premature Discharge of Battery

  INFORMATION WAS RECEIVED FROM A PATIENT (PT) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). PATIENT MENTIONED THEY GOT THEIR FIRST IMPLANT IN THE US, A NON-RECHARGEABLE IMPLANT, THAT WAS SUPPOSED TO LAST 5 YEARS BUT LAST 5 YEARS. PATIENT THEN MENTIONED THEY GOT THEIR 2ND IMPLANT, A RECHARGEABLE IMPLANT, IN 2016 OR 2017 IN PUERTO RICO. [SEE 708769303 FOR RELATED EVENT].

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23829565 ↗
• MalfunctionDec 2, 2025Intermittent Continuity; Battery Problem; Intermittent Continuity; Battery Problem

  INFORMATION WAS RECEIVED FROM A PATIENT (PT) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REASON FOR CALL WAS PATIENT MENTIONED THEIR SPINAL CORD STIMULATOR BATTERY WAS GOING REAL LOW. PATIENT SAID THEY TURNED THEIR THERAPY OFF SOMETIMES DURING THE DAY BECAUSE THE THERAPY INTERFERED WITH WHAT THEY WERE DOING DURING THE DAY, AND WHEN THE THERAPY CAME BACK ON, THE THERAPY WOULD TURN OFF RIGHT AWAY. PATIENT MENTIONED THEY COULD TELL THE SPINAL CORD STIMULATION BATTERY WAS GETTING WEAK. PT MENTIONED ISSUES STARTED ABOUT 2 WEEKS AGO. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 23693388 ↗
• MalfunctionNov 24, 2025Migration or Expulsion of Device; Insufficient Device Problem Information; Migration or Expulsion of Device; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT THAT MENTIONED THEIR IMPLANTABLE NEUROSTIMULATOR (INS) WAS NOT WORKING AND THAT THE LEAD CAME LOOSE BUT CAN'T BE REMOVED DUE TO PARALYSIS RISK.

  Patient problems: Insufficient Information

  MAUDE report 23631322 ↗
• MalfunctionNov 19, 2025Low impedance; Low impedance

  PT HAS SCS SYSTEM FOR BACK PAIN. PT HASN'T USED HER SCS SYSTEM BECAUSE SHE WASN'T GETTING PAIN RELIEF. CALLER INCREASING STIM BUT PT NOT FEELING STIM WITH INCREASE IN STIM INITIALLY WITH VARIOUS ELECTRODES AND CHANGING PW HELPED GET SOME STIM SENSATION IN BACK AREA (TARGET AREA) USING 5.4V USING ELECTRODES 0 THRU 3, DOUBLE GUARDED CATHODE. PT HAD LOST THEIR STIM BENEFIT OVER A YEAR AGO. IMPEDANCES ON ELECTRODES THAT THE PT HAD BEEN USING WERE: 1-2 (3364), 1-3 (1639); 2-3 (2101); 3-4 (3488), 5-6 (1600); 5-7 (1821) AND 6-7 (1503). WHEN TRYING TO MEASURE A GROUP IMPEDANCE ON GROUP C, THERE WAS A MESSAGE ON SCREEN ABOUT "LOW IMPEDANCE" ON GROUP C AND THE SYSTEM WAS NOT ALLOWING HIM TO MEASURE A GROUP IMPEDANCE. TSS DID LONGEVITY CALC BASED ON: 5.4V, 300US, 40HZ, 20 HR/DAY USE AND DOUBLE GUARDED CATHODE = 2.1 YRS TO EOS. TSS REVIEWED THIS WAS FOR NEW INS. PT'S CURRENT BATTERY CAPACITY WAS SHOWING AS 3.0V SO THAT PT DID HAVE SOME CAPACITY LEFT BUT HARD TO ESTIMATE EXACTLY HOW LONG.

  Patient problems: Pain

  MAUDE report 23594573 ↗
• InjuryNov 14, 2025Break; Migration or Expulsion of Device; Break; Migration or Expulsion of Device

  THE DEVICE WAS REMOVED DUE TO CARDIAC ISSUE. ONE LEAD HAD WITHDRAWN AND THE OTHER LEAD WAS CUT BUT COULD NOT DETERMINE WHICH SERIAL NUMBER WAS CUT OR WITHDRAWN.

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

  MAUDE report 23555763 ↗

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