N/A 97725 (UDI 00763000689469)Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 00763000689469), received between Sep 28, 2023 and Mar 7, 2025 — classified as 34 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (5 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 25 most recent of 45 reports, in the reporter's own words as published by the FDA.

• InjuryMar 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A DISTRIBUTOR REGARDING A TRIAL PATIENT WHO WAS USING AN WIRELESS EXTERNAL NEUROSTIMULATOR (WENS). IT WAS REPORTED THAT DURING THE FIRST PHASE TEST OF THE WENS STIMULATION, STAFF FEEDBACK NOTED AN INFECTION. NO SURGICAL INTERVENTION OCCURRED OR WAS PLANNED. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. THE PATIENT WAS ALIVE WITH NO INJURY AT THE TIME OF THE REPORT.

  Patient problems: Unspecified Infection

  MAUDE report 21549645 ↗
• MalfunctionJan 13, 2025High impedance; Malposition of Device; High impedance; Malposition of Device

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE REP WANTED TO INQUIRE ABOUT AN IMPEDANCE ISSUES OBSERVED WITH AN SCS LEAD DURING DIFFERENTIAL TARGET MULTIPLEXED (DTM) PROGRAMMING. AS SHOWN IN THE PROVIDED IMAGE, WHEN THE LEAD WAS POSITIONED IN THE MIDDLE LINE, THEY ENCOUNTERED IMPEDANCE PROBLEMS (PER THE PROVIDED IMAGES - ELECTRODES 1-3, GREATER THAN 40000, THEN 1-6 GREATER THAN 40000, AND THEN ALL ELECTRODES GREATER THAN 40000). IT WAS UNDERSTOOD THAT 2 LEADS SHOULD BE PLACED SEPARATELY, BUT GUIDELINES WERE REQUESTED ON THE REQUIRED SPACING. THEY WERE HAVING TROUBLE COMMUNICATING THIS TO THEIR HCPS, AND HAVING A BASE PROTOCOL WITH PRECISE NUMERICAL GUIDANCE WOULD BE GREATLY HELPFUL. AS WELL, IT WAS ASKED IF THERE WERE ANY DIFFERENCES IN RECOMMENDED SETTINGS OR PROCEDURES BETWEEN EXTERNAL NEUROSTIMULATORS (WENS) AND IMPLANTED NEUROSTIMULATORS (INS) WHEN PERFORMING DTM PROGRAMMING. THE IMPEDANCE INTERFERENCE USUALLY ONLY OCCURS DURING THE TRIAL PHASE AND NOT AFTER INS IMPLANTATION. TRAINING <(>&<)> EDUCATION RESPONDED THAT THERE WAS NO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21139156 ↗
• MalfunctionDec 13, 2024Failure 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 MANUFACTURER REPRESENTATIVE REGARDING A TRIAL PATIENT WHO WAS USING A WIRELESS EXTERNAL NEUROSTIMULATOR (WENS). IT WAS REPORTED THAT THE WENS WOULDN'T CONNECT, BUT STILL WORKED. THE WENS WOULD NOT CONNECT TO THE REMOTE OR TABLET FROM MID TRIAL UNTIL END OF TRIAL. REP PRESSED THE BUTTON REPEATEDLY, AND WHEN DEVICE WAS REMOVED THE REP REPLACED THE BATTERIES TO SEE IF THAT WAS THE ISSUE, BUT THE DEVICE STILL WOULDN'T TURN ON. THE REP REPORTED THE PATIENT WAS NOT IMPACTED BY THE ISSUE. THE CAUSE WAS NOT DETERMINED, BUT THE REP REPORTED THEY WOULD SUBMIT ANY NEW INFORMATION THAT BECOMES AVAILABLE. THE DEVICE WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20926944 ↗
• InjuryJun 21, 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 SPINAL CORD STIMULATOR (SCS) TRIAL. IT WAS REPORTED THERE WAS INTRA-OP PAIN AND POST PROCEDURE PAIN ATTRIBUTED TO THE LEAD. THE DEVICE WAS TURNED OFF, BUT THE CAUSE WAS NOT DETERMINED AND THE ISSUE IS NOT YET RESOLVED. THE TRIAL LEAD WAS REMOVED AND DISPOSED OF BY A NURSE. ON 2024-MAY-30 THE REP REPORTED THEY WERE NOTIFIED THE DAY OF THE TRIAL ON 2024-MAY-23.

  Patient problems: Intraoperative Pain; Pain

  MAUDE report 19580589 ↗
• MalfunctionJun 18, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  THE REP PROVIDED THE SERIAL NUMBERS FOR DEVICES INVOLVED. THE CAUSE OF THE LEAD MIGRATION WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19560530 ↗
• InjuryJun 17, 2024Application Program Problem; Adverse Event Without Identified Device or Use Problem; Application Program Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP) REPORTING THAT THE TRIALING APP WAS THE MOST RECENT VERSION THAT IS COMPATIBLE WITH INCEPTIV HANDSETS ONLY. THE ISSUE IS THE INTELLIS CONTROLLERS ARE NOT COMPATIBLE WITH THE NEW STIM TRIALING APP.

  Patient problems: Hematoma; Muscle Weakness/Atrophy

  MAUDE report 19545768 ↗
• InjuryJun 14, 2024Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  INFORMATION WAS RECEIVED FROM A TRIAL PATIENT VIA MANUFACTURER REPRESENTATIVE WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS). PATIENT DESCRIBED SHOCKING AND BROKE OUT IN HIVES DURING THE TRIAL. PATIENT WENT TO EMERGENCY ROOM (ER), AND HOSPITALIZATION WAS NOTED. PATIENT CLAIMED WITH DEVICE OFF SHOCKING WAS LESS BUT STILL OCCURRED. THE CAUSE IS UNKNOWN. THIS OCCURRED THE SECOND DAY OF THE TRIAL. THE LEADS USED FOR THE TRIAL WERE PRODUCTS OWNED BY THE CUSTOMER THAT THEY WISHED TO USE FOR THE TRIAL. THE TRIAL DEVICES WERE REMOVED AND DISCARDED, AND THIS RESOLVED THE ISSUE.

  Patient problems: Electric Shock; Urticaria

  MAUDE report 19538022 ↗
• InjuryJun 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A TRIAL PATIENT (PT) VIA MANUFACTURER REPRESENTATIVE (REP) WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS). IT WAS REPORTED THAT THE PT REPORTS SWEATING AND LOW GRADE FEVER. PT STATES THEY DID NOT PICK UP ANTIBIOTICS THAT OFFICE CALLED IN FOR THEM. HCP NOTIFIED OF ISSUE AND ADVISED PT TO RETURN TO OFFICE ON ASAP FOR LEAD PULL APPT.

  Patient problems: Diaphoresis; Fever; Unspecified Infection

  MAUDE report 19511602 ↗
• InjuryMay 30, 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 TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS). TRIAL LEADS PLACED, PATIENT DISCHARGED TO HOME. COMPLAINED OF SHARP, SHOOTING PAIN AND WENT TO ER. DIRECTED PATIENT TO TURN STIMULATOR OFF. EMERGENCY ROOM DOCTOR REMOVED TRIAL LEADS.

  Patient problems: Pain

  MAUDE report 19424779 ↗
• InjuryMay 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (TRIAL PATIENT, MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A TRIAL P ATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS). IT WAS REPORTED THAT THE PATIENT WAS HAVING SOME LEG WEAKNESS. MANUFACTURER REPRESENTATIVE (REP) REPORTED SYMPTOMS TO HEALTHCARE PROVIDER (HCP) AND HE INSTRUCTED PATIENT TO GO TO ER TO BE CHECKED. A DIFFERENT HCP STATES PT HAS FLUID IN THE SPINAL CANAL, THEY ARE UNSURE IF IT IS "BLADDER FLUID", PATIENT HAS A TEMP. HCP CALLED AND REPORTED THE PATIENT HAD AN EPIDURAL HEMATOMA AND HAD SURGERY LAST NIGHT TO STOP THE BLEEDING. CAUSE WAS DESCRIBED AS LEAD PLACEMENT FOR SCS TRIAL FOR LEFT LEG PAIN. PATIENT HAD HAD AN MRI WHICH SHOWED BLEEDING. EPIDURAL BLEED, PATIENT IS IN HOSPITAL. PATIENT STILL HAS LEG WEAKNESS, HOPING FOR A FULL RECOVERY BUT UNKNOWN CURRENTLY. ISSUE IS ONGOING.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding; Muscle Weakness/Atrophy

  MAUDE report 19416450 ↗
• InjuryMay 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). THE REP REPORTED THAT TRIAL SYSTEM REMOVED AT HOSPITAL. THE ISSUE HAS BEEN RESOLVED.

  Patient problems: Fever; Headache; Unspecified Infection

  MAUDE report 19371042 ↗
• InjuryMay 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURING REPRESENTATIVE VIA EMAIL. REP STATED THEY HAVE BEEN TRYING TO GATHER ADDITIONAL INFORMATION BUT THERE IS NO NEW INFORMATION SINCE THIS REPORT WAS FILED. HERE ARE THE MOST UP-TO-DATE ANSWERS THAT THE REP CAN PROVIDE. ISSUE HAS BEEN RESOLVED. REP WAS ASKED ABOUT STATUS OF THE REMOVED LEADS AND REP STATED CUSTOMER DISCARDED. DEVICE NOT AVAILABLE AND NOT RETURNED. INFORMATION WAS PROVIDED BY PHYSICIAN AND CONFIRMED.

  Patient problems: Discomfort; Pain

  MAUDE report 19347882 ↗
• InjuryMay 17, 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 TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS). CALLER REPORTS PATIENT HAD A TRIAL TODAY. PATIENT WAS DOING FINE, BUT POST OP, PATIENT HAD EXTREME PAIN ON BILATERAL LEGS AND FEET. CALLER REPORTS PHYSICIAN THEN PULLED EVERYTHING OUT. CALLER REPORTS WHEN SHE LEFT, PATIENT WAS BEING MONITOR AND SHE WAS DOING FINE. CALLER REPORTS SHE HAS NOT RECEIVED ANY CALL OTHERWISE.

  Patient problems: Pain

  MAUDE report 19342190 ↗
• MalfunctionMay 16, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  ADDITIONAL INFORMATION FROM THE REP INDICATED THAT THE PATIENT WANTED TO MOVE FORWARD BUT PHYSICIAN WAS UNSURE IF HE HAD ADEQUATE TIME WITH CORRECT LEAD PLACEMENT. UNDECIDED AS OF NOW IF THE TRIAL WAS SUCCESSFUL. NO SYMPTOMS WERE REPORTED FROM THE LEAD MIGRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19333466 ↗
• MalfunctionMay 15, 2024Connection Problem; Impedance Problem; Material Twisted/Bent; Connection Problem; Impedance Problem; Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE (REP), HEALTHCARE PROVIDER (HCP)) REGARDING A TRIAL PATI ENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (WENS). IT WAS REPORTED THAT THEY WERE UNABLE TO CONNECT WITH 2 DIFFERENT WENS IN THE HEADER.  REP REPORTED CONNECTIVITY CHECK SHOWED NOT ALL CONTACTS CONNECTED TO THE WENS. THE LEAD WAS RE-SEATED MULTIPLE TIMES IN TWO DIFFERENT WENS. DIFFERENT CONTACTS OUT EACH TIME REP HCP CHECKED.  UPON VISIBLY INSPECTING THE LEAD, A KINK WAS VISIBLE IN THE STYLET AT THE LOCATION OF THE PROXIMAL CONTACTS. REP REPORTED THE LEAD WAS NEVER IMPLANTED, AND WAS RETURNED FOR ANALYSIS. REP REPORTED THAT THE ISSUE WAS RESOLVED. FIELD REP REPORTED THEY WOULD FOLLOW-UP WITH ANY NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19325669 ↗
• InjuryMay 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM AN UNKNOWN SOURCE REGARDING A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS). IMMEDIATELY AFTER SPINAL CORD STIMULATOR TRIAL LEAD PLACEMENT PROCEDURE ON (B)(6), PATIENT REPORTED FOOT PAIN THAT WAS WORSE THAN THEIR BASELINE PAIN. TURNING ON STIMULATION DID NOT APPEAR TO AFFECT THE PAIN (NEITHER HELPING NOR EXACERBATING). PATIENT WAS SENT HOME ON DTM SETTINGS. THE NEXT DAY, PATIENT SAID THAT THE PAIN REPORTED AFTER THE PROCEDURE HAD NOT IMPROVED, AND THAT SCS THERAPY EXACERBATED THE PAIN, SO PT TURNED IT OFF. PT CONTACTED THE PHYSICIAN'S OFFICE AND REQUESTED THAT LEADS BE REMOVED.

  Patient problems: Pain

  MAUDE report 19315146 ↗
• InjuryMay 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A TRIAL PATIENT VIA MANUFACTURER REPRESENTATIVE WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS). AFTER PROCEDURE, PATIENT EXPERIENCED LEG PAIN IN THE RECOVERY AREA. DOCTOR BELIEVES, ¿NERVE ROOT WAS IRRITATED FROM PROCEDURE.¿ DOCTOR TRANSFERRED PATIENT TO HOSPITAL AS A PRECAUTION SO THAT THEY COULD MANAGE PAIN. DOCTOR BELIEVES NERVE PAIN WILL BE TEMPORARY. DOCTOR REMOVED DEVICE AS A PRECAUTION, ELECTED NOT TO CONTINUE WITH THE TRIAL.

  Patient problems: Nerve Damage; Pain

  MAUDE report 19305010 ↗
• InjuryMay 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A TRIAL PATIENT VIA MANUFACTURER REPRESENTATIVE WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS). PATIENT WAS ADMITTED TO HOSPITAL. PATIENT WENT TO ER FOR STOMACH AND BACK PAIN. DEVICE WAS TURNED OFF. PT STATED NOT BEING ABLE TO WALK. NUMBNESS/WEAKNESS IN LEGS. PT STATED SHE WAS TOLD THERE MAY BE A BLOOD CLOT IN SPINAL COLUMN. PT STATED SCS TRIAL DEVICE WAS REMOVED ON 4/19. TRIALING HCP UPDATED WITH THIS INFORMATION. NO OTHER KNOWN INFORMATION AT THIS TIME.

  Patient problems: Ambulation or Postural Difficulties; Muscle Weakness/Atrophy; Numbness; Pain; Thrombosis/Thrombus

  MAUDE report 19269480 ↗
• MalfunctionApr 18, 2024Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). CALLER STATES THE PATIENT NOTED TODAY AFTER IMPLANT THAT THEY ARE EXPERIENCING SHOCKING AND VIBRATING SENSATIONS INTO HER STOMACH. DURING THE CALL, THE CALLER FOUND A MOBILE NUMBER FOR THE REP AND PLANS TO CALL HIM. TECHNICAL SERVICES ADVISED CALLER TO CALL BACK IF UNABLE TO REACH THE REP.

  Patient problems: Electric Shock; Insufficient Information

  MAUDE report 19140374 ↗
• InjuryApr 16, 2024Migration or Expulsion of Device; Energy Output Problem; Electromagnetic Compatibility Problem; Patient Device Interaction Problem; Migration or Expulsion of Device; Energy Output Problem; Electromagnetic Compatibility Problem; Patient Device Interaction Problem

  ADDITIONAL INFORMATION FROM THE REP INDICATED THAT THE IMPLANT DATE OF THE TRIAL LEADS WAS (B)(6) 2024. THEY STATED THAT NO X-RAYS WERE TAKEN, SO THEY CANNOT RULE IN OR OUT WHETHER LEADS WERE DISLODGED/MIGRATED. THEY STATED THAT THE CAUSE OF THE TINGLING SENSATIONS WERE UNKNOWN. THEY STATED THAT THE DEVICE WAS SHUT OFF. SUBSEQUENTLY PATIENT WAS UNABLE TO MOVE AND ADMITTED TO THE HOSPITAL FOR 2 DAYS. THE REP STATED THAT THE TINGLING EVENTUALLY STOPPED AND PATIENT REGAINED ABILITY TO MOVE AND WAS DISCHARGED FROM HOSPITAL

  Patient problems: Ambulation or Postural Difficulties; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19121120 ↗
• InjuryApr 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A TRIAL PATIENT VIA MANUFACTURER REPRESENTATIVE WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS). PATIENT REPORTED SHORTNESS OF BREATH AND HEART PAIN. THE PATIENT IS CURRENTLY IN THE ER. HOSPITALIZATION WAS NOTED. NO TROUBLESHOOTING HAS BEEN PERFORMED. THE CAUSE IS UNKNOWN, BUT THE ISSUE HAS BEEN ATTRIBUTED TO THE LEADS. IT IS UNKNOWN IF THE ISSUE HAS BEEN RESOLVED, BUT THE REP WILL REPORT ANY NEW INFORMATION THAT BECOMES AVAILABLE.

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

  MAUDE report 19089354 ↗
• MalfunctionApr 3, 2024Impedance Problem; Impedance Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP. THE REP REPORTED IT WAS A CONNECTION ISSUE, AS WHEN THE REP CHECKED CONNECTIVITY IT SHOWED A RED X ON FOUR ELECTRODES. THE REP WILL BE RETURNING THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19034544 ↗
• InjuryMar 13, 2024Therapy Delivered to Incorrect Body Area; Positioning Problem; Therapy Delivered to Incorrect Body Area; Positioning Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (PATIENT, MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER (HCP)S REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THE HCP HAD SIGNIFICANT DIFFICULTY ACCESSING EPIDURAL SPACE DUE TO DDD AND TIGHT EPIDURAL SPACE. ABLE TO ACCESS WITH FIRST LEAD, SECOND ACCESS TOOK EVEN LONGER AND ACCESS NEEDLE BECAME CLOGGED AND BLOCKED LOSS OF RESISTANCE (LOR) SYRINGE FROM INDICATING WHEN THEY HAD ACCESSED EPIDURAL SPACE. ONCE HCP ACHIEVED LOR BOTH LEADS WERE ANTERIOR AND HCP WAS UNABLE TO GET THEM POSTERIOR DESPITE MULTIPLE ATTEMPTS. BOTH NEEDLES WERE THEN NOTED TO BE DRIPPING WHAT APPEARED TO BE CSF. HCP OPTED TO ABANDON ATTEMPT AT IMPLANT DUE TO FEAR OF INTRATHECAL TAP AND WILL BE SENDING PT FOR PADDLE IMPLANT. PT AWOKE WITH SORENESS AT ACCESS SITE AND SLIGHT HEADACHE, BUT WEAKNESS OR CHANGES IN SENSATION. SENSATION OF STIM IN STOMACH WAS ALSO REPORTED. THE ISSUE WAS RESOLVED WITH REMOVAL OF THE LEADS. THE LEADS WERE DISCARDED. THE REP WILL REPORT ADDITIONAL INFORMATION THAT BECOMES AVAILABLE. ON 2024-MAR-12 THE REP REPORTED THE LEADS WERE CONNECTED TO A WENS AND PROVIDED THE SERIAL NUMBER.

  Patient problems: Cerebrospinal Fluid Leakage; Discomfort; Headache; Insufficient Information; Muscle Weakness/Atrophy; Undesired Nerve Stimulation

  MAUDE report 18893123 ↗
• InjuryMar 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REP PROVIDED THE SERIAL NUMBER OF THE WENS.

  Patient problems: Ambulation or Postural Difficulties; Hematoma

  MAUDE report 18858141 ↗
• InjuryFeb 26, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS). HCP ADVISED THAT THE PATIENT¿S ORIGINAL TRIAL LEADS MIGRATED DOWN DUE TO HER HUNCHING OVER IN HER WHEELCHAIR. HE DECIDED TO PLACE RETRIAL LEADS A LEVEL HIGHER THIS TIME TO HELP WITH THAT. THE HCP ADVISED THAT IF THE RETRIAL IS SUCCESSFUL FOR THIS PATIENT, HE WILL MOST LIKELY USE A PADDLE LEAD TO HELP AVOID ANY MIGRATION WITH HER POSTURE. THE MANUFACTURER REPRESENTATIVE (REP) INDICATED THEY WOULD SEND ANY FURTHER INFORMATION AS THEY BECOME AWARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18783129 ↗

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