Specify® SureScan® MRI 5-6-5 977C165Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00643169464599), received between Dec 16, 2016 and Dec 11, 2025 — classified as 12 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2025Break; Environmental Compatibility Problem; Human-Device Interface Problem; Break; Environmental Compatibility Problem; Human-Device Interface Problem

  THE REP REPORTED THEY WERE NOT IN THIS CASE AND DO NOT PATIENT INFORMATION OR ANY ADDITIONAL INFORMATION AND REPEATED HOW A HCP HAD CONTACTED THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23782806 ↗
• MalfunctionJan 21, 2025Malposition of Device; Malposition of Device

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). THE PATIENT MENTIONED ON THE CALL THAT THE STIMULATOR LEADS WERE NOT IN THE RIGHT PLACE, AND THEY WERE TRYING TO GET THAT FIXED. THE PATIENT STATED THEY WERE TRYING TO GET THE LEADS FIXED AND "PUSHED BACK UP WHERE THEY WERE SUPPOSED TO GO" BUT THEY NEEDED THE MRI FIRST. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21197544 ↗
• InjuryOct 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). THE PATIENT WAS HAVING A TRIAL AND HAD A DURAL PUNCTURE SO THE SURGEON DECIDED TO GO TO A PADDLE LEAD AS THE SPINE WAS DIFFICULT FOR ENTRY. THE PADDLE WENT IN WELL AND THE PATIENT WAS PROGRAMMED. THE NEXT DAY IT WAS FOUND THAT THE PADDLE WAS REMOVED OVERNIGHT DUE TO AN EPIDURAL HEMATOMA AND THAT UPON REMOVAL THE PATIENT¿S LEG STRENGTH NORMALIZED. IT WAS NOTED THAT THE PATIENT HAD BEEN KEPT OVERNIGHT IN THE HOSPITAL. THE PATIENT HAD RETURNED TO NORMAL, THE ISSUE WAS RESOLVED AND THE CAUSE WAS NOT KNOWN.

  Patient problems: Cerebrospinal Fluid Leakage; Hematoma; Muscle Weakness/Atrophy

  MAUDE report 17958811 ↗
• InjuryOct 14, 2022Disconnection; Inappropriate/Inadequate Shock/Stimulation; Disconnection; Inappropriate/Inadequate Shock/Stimulation

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR SPINAL PAIN INDICATIONS. THE PATIENT REPORTED THAT ABOUT 3 MONTHS PRIOR (AROUND (B)(6) 2022 THEIR LEAD PULLED AWAY FROM THE COMPETITOR ADAPTOR/EXTENSION.  AS A RESULT, THEY WERE GETTING SHOCKED ANY TIME THEY WOULD TURN THE COMPETITOR IMPLANTED NEUROSTIMULATOR (INS) ON.  THEIR DOCTOR WILL BE REPLACING THE COMPETITOR INS WITH A MANUFACTURER INS AS REPLACING THE INS WOULD BE SAFER THAN REPLACING THEIR CURRENT PADDLE LEAD.  THE REPLACEMENT SURGERY IS SCHEDULED FOR (B)(6), 2022.  PT NOTED THEY NEED AN MRI COMPATIBLE SYSTEM.    PT REQUESTED TO SPEAK TO A MANUFACTURER REPRESENTATIVE (REP) TO DISCUSS INS OPTIONS BEFORE THE DATE OF SURGERY.  A MESSAGE WAS SENT OUT TO THE REPS TO NOTIFY THEM OF THE PTS REQUEST.

  Patient problems: Electric Shock

  MAUDE report 15610560 ↗
• MalfunctionMay 6, 2022Failure 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 MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS IMPLAN TED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT DURING LEAD PLACEMENT WITH NEUROMONITORING POOR/NO RESPONSE WAS NOTED DURING EXTENSIVE ATTEMPTS AT TESTING. IMPEDANCES WERE NORMAL. CONNECTIVITY. POSSIBLE LEAD AND WENS FAILURE WAS A DIFFERENTIAL DIAGNOSIS SO LEAD AND WENS WASTED AND NEW LEAD AND WENS USED WITH SAME RESULTS. MD WOULD LIKE LEAD EVALUATED. WENS WAS DISCARDED BY SCRUB TECH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14306343 ↗
• MalfunctionApr 18, 2022Impedance Problem; Impedance Problem

  INFORMATION WAS RECEIVED FROM A PATIENT VIA A MANUFACTURER REPRESENTATIVE (REP) WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR NON-MALIGNANT PAIN AND COMPLEX REG PAIN SYNDROME TYPE II. IT WAS REPORTED THAT THE PATIENT HAD 4 ELECTRODES THAT WERE OOR-2,3,4 & 7. THE MANUFACTURER REPRESENTATIVE (REP) INTERROGATED THE BATTERY AND RAN AN IMPEDANCE CHECK. THE REP PROGRAMMED AROUND AFFECTED ELECTRODES. THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14135599 ↗
• InjuryMar 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). THE PATIENT HAS A MEDICAL HISTORY OF DEGENERATIVE DISC DISEASE AND SPINAL STENOSIS. IT WAS REPORTED THAT WHEN THE PATIENT'S LEAD WAS PUT IN NEUROMONITORING SHOWED REDUCED SIGNALS IN THE PATIENT'S LEGS AND CORD COMPRESSION. THEY DECOMPRESSED T10, T9 AND T8. THE LEAD WAS REMOVED AND THE PROCEDURE WAS ABORTED. IT WAS REPORTED THAT SIGNALS WERE RETURNING AND THE ISSUE WAS RESOLVED AT TIME OF THE REPORT.  FACTORS THAT MAY HAVE CONTRIBUTED TO THIS WAS ADVANCE PATIENT AGE AND NARROW SPINAL CANAL.

  Patient problems: Ambulation or Postural Difficulties; Spinal Cord Injury

  MAUDE report 13657625 ↗
• MalfunctionMar 2, 2022Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT DURING INTRA-OP OF IMPLANTING LEAD, THERE WAS AN ELECTRODE THAT WAS BROKEN OFF SO A NEW LEAD WAS OPENED AND USED. ISSUE IS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13653887 ↗
• MalfunctionJan 6, 2022Impedance Problem; Impedance Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT CONTACTS 2 AND 4 SHOWED A BAD CONNECTION NO MATTER WHICH CHANNEL IT WAS PLUGGED INTO IN THE WENS AND THE INS. IT WAS UNKNOWN IF THERE WERE ANY CONTRIBUTING FACTORS. THE SURGEON WIPED THE LEADS OFF WITH A DAMP RAY TECH AND A DRY ONE, CHANGED THE LEAD TAILS BETWEEN THE TWO CHANNELS IN THE WENS AND THE INS AND THE BAD CONNECTION FOLLOWED THE LEAD TAIL ON THE FIRST LEAD. THAT LEAD WAS THEN SWAPPED OUT AND A NEW LEAD WAS USED. THIS LEAD HAD THE SAME BAD CONNECTIONS ON THE SAME LEAD TAIL REGARDLESS OF THE CHANNEL IN BOTH THE WENS AND INS. THE SURGEON CONTINUED TO WIPE AND READJUST AND EVENTUALLY CONTACT 4 IMPROVED, BUT CONTACT 2 REMAINED WITH A BAD CONNECTION. IN THE END THIS LEAD SHOWED CONTACTS 2 AND 4 WERE NORMAL, BUT CONTACT 6 SHOWED RED (40 ,000).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13185481 ↗
• InjuryDec 15, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM AN HEALTH CARE PROFESSIONAL (HCP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR SPINAL PAIN. IT WAS REPORTED THAT  THE PT DEVELOPED CHEST PAIN A COUPLE OF DAYS AFTER LEAD IMPLANT AND WENT TO THE ER. SHE RECEIVED A MEDTRONIC PACEMAKER AND WAS HOSPITALIZED. SHE STILL COULD NOT USE HER LEFT LEG AFTER NEARLY 2 WEEKS OF WORKING WITH PHYSICAL THERAPY, SO SURGEON OPTED TO REMOVE PADDLE. HE SAID THERE WAS A LOT OF FIBROUS TISSUE AROUND THE PADDLE. PT'S LEG MOBILITY IMPROVED SLIGHTLY AFTER EXPLANT. THE PADDLE LEAD WAS IMPLANTED ON (B)(6) 2021, AND EXPLANTED ON (B)(6) 2021. SURGEON REPORTS PATIENT COULD NOT MOVE LEGS IN RECOVERY BUT WAS ABLE TO MOVE THE RIGHT LEG. PADDLE LEAD EXPLANT (B)(6) 2021 IPG REMAINS IMPLANTED.

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

  MAUDE report 13011711 ↗
• InjuryNov 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED. PATIENT INFORMATION WAS PROVIDED. UNKNOWN IF ISSUE IS RESOLVED.

  Patient problems: Muscle Weakness/Atrophy

  MAUDE report 12883635 ↗
• MalfunctionSep 9, 2021Break; Impedance Problem; Break; Impedance Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE PADDLE LEAD WAS TESTED INTRA-OP, AND THE CONNECTIVITY CHECK SHOWED THAT CONTACT #2 WAS RED. THE LEAD WAS WIPED OFF MULTIPLE TIMES WITH DRY AND WET CLOTH AND STILL THE SAME ELECTRODE WAS COMING UP AS RED. THE PHYSICIAN SWITCHED THE LEADS IN THE BATTERY, AND THE SAME CONTACT WAS COMING UP AS FAULTY. CONTACT #2 ON THE PADDLE WAS BROKEN. THE LEAD WAS REPLACED TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12448637 ↗
• InjuryJan 4, 2021Adverse Event Without Identified Device or Use Problem; Positioning Problem; Adverse Event Without Identified Device or Use Problem; Positioning 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 THAT THE PATIENT HAD A LOSS OF MOTOR TESTING SIGNALS FOR THE RIGHT LOWER EXTREMITY DURING PADDLE PLACEMENT. IT WAS UNKNOWN WHAT LED TO THE ISSUE. THE PADDLE WAS REMOVED AND PERFUSION WAS INCREASED INTRAOPERATIVELY. IT WAS UNKNOWN IF THE ISSUE WAS RESOLVED.

  Patient problems: Insufficient Information; Unspecified Nervous System Problem

  MAUDE report 11111601 ↗
• InjuryJun 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED BY A MANUFACTURE REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). INFORMATION WAS REPORTED THAT DURING THE PATIENT'S LEAD IMPLANT PROCEDURE THEY HAD A LOSS OF MOTOR SIGNAL. THE LEAD WAS REMOVED FROM THE PATIENT AND THE SURGEON FINISHED WITH WOUND CLOSURE. AFTER THE PATIENT WAS CLOSED UP THEY REGAINED 60% OF THEIR MOTOR SIGNAL. ADDITIONAL INFORMATION WAS REPORTED THAT THE CAUSE OF THE LOSS OF MOTOR SIGNAL WAS NOT DETERMINED. THE PATIENT WAS SENT HOME FROM THE HOSPITAL TODAY ((B)(6) 2020) WITH 100% RETURN OF MOTOR SIGNAL. THE ISSUE WAS RESOLVED. NO FURTHER INFORMATION WAS REPORTED.

  Patient problems: Neurological Deficit/Dysfunction

  MAUDE report 10207108 ↗
• MalfunctionFeb 19, 2020Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR. IT WAS REPORTED THAT THE PATIENT WAS IN FOR A FULL SYSTEM REPLACEMENT TO UPDATE TO MRI SCAN MODELS. DURING LEAD MANIPULATION OF THE NEW LEADS IN EPIDURAL SPACE, THE ELECTRODE CAUGHT TISSUE FORCEPS AND LIFTED OFF THE LEADS. IT WAS REPORTED THAT A CONTRIBUTING FACTOR WAS SCAR TISSUE IN EPIDURAL SPACE FROM EXPLANTED LEADS. DIFFERENT LEAD MODELS WERE OPENED AND WERE USED SUCCESSFULLY AND FIT IN THE SPACE WITH EASE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9729797 ↗
• MalfunctionFeb 19, 2020Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR. IT WAS REPORTED THAT THE PATIENT WAS IN FOR A FULL SYSTEM REPLACEMENT TO UPDATE TO MRI SCAN MODELS. DURING LEAD MANIPULATION OF THE NEW LEADS IN EPIDURAL SPACE, THE ELECTRODE CAUGHT TISSUE FORCEPS AND LIFTED OFF THE LEADS. IT WAS REPORTED THAT A CONTRIBUTING FACTOR WAS SCAR TISSUE IN EPIDURAL SPACE FROM EXPLANTED LEADS. DIFFERENT LEAD MODELS WERE OPENED AND WERE USED SUCCESSFULLY AND FIT IN THE SPACE WITH EASE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9729786 ↗
• MalfunctionOct 7, 2019High impedance; Connection Problem; High impedance; Connection Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO IS IMPLANTED WITH A NEUROSTIMULATOR. IT WAS REPORTED THAT THEY DID A NEW PADDLE LEAD IMPLANT ON THE DAY OF THE REPORT AND THE CHECK CONNECTIVITY SHOWED TWO CONTACTS OUT (COULD NOT RECALL WHICH TWO.) UPON ELECTRODE IMPEDANCE CHECK, ONLY CONTACTS 6 AND 7 SHOWED GREATER THAN 40,000 OHMS. THE HEALTH CARE PROFESSIONAL PULLED OUT AND REPOSITIONED THE LEAD SEVERAL TIMES ALONG WITH PUTTING THE LEAD INTO THE 8-15 PORT OF THE IMPLANTABLE NEUROSTIMULATOR. WHEN IN THE 8-15 PORT, 13 AND 14 SHOWED 40,000 OHMS. IT WAS CONFIRMED THAT IT WAS THE SAME CONTACTS AS PRIOR TO SWAPPING THE PORTS. THEY RAN IMPEDANCES SEVERAL TIMES, AND IT WAS CONSISTENTLY THE SAME CONTACTS IN EITHER PORT THAT WERE OVER 40,000 OHMS. THE OTHER CONTACTS HAD NORMAL, IN RANGE IMPEDANCES. WHEN THE PHYSICIAN¿S ASSISTANT WAS INSERTING THE LEAD INTO THE HEADER BLOCK, THE LEAD BENT SLIGHTLY ON THE WHITE MARKER BAND ON THE LEAD TAIL. THEY WERE NOT COMFORTABLE USING THE LEAD AS MOST OF THE PATIENT¿S PAIN IS ON THE LEFT SIDE, SO A NEW LEAD WAS USED WITH NO ISSUES. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9162718 ↗
• InjurySep 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING THE PATIENT. IT WAS REPORTED THAT THE PATIENT HAS REGAINED FUNCTION IN BOTH LEGS, BUT THE LEFT LEG IS STILL A LITTLE WEAK. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Ambulation or Postural Difficulties; Muscle Weakness/Atrophy

  MAUDE report 9119219 ↗
• MalfunctionSep 9, 2019Impedance Problem; Impedance Problem

  INFORMATION WAS RECEIVED BY A MANUFACTURER REPRESENTATIVE (REP) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS) LEAD. IT WAS REPORTED THAT THERE WAS AN IMPEDANCE ISSUE ON THE LEAD. THE REP TOOK THE LEAD OUT OF THE BATTERY MULTIPLE TIMES, WIPED THE CONTACTS DOWN, RE-INSERTED THE LEAD AND THE SAME 2 ELECTRODES KEPT SHOWING IMPEDANCE ISSUES. THE LEAD PORTS IN THE BATTERY WERE SWITCHED AND THE SAME 1 ELECTRODE SHOWED IMPEDANCE ISSUES. THE LEAD WAS REPLACED AND THE ISSUE WAS RESOLVED. THE LEAD WAS EXPECTED TO BE RETURNED FOR ANALYSIS. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8977507 ↗
• MalfunctionDec 14, 2018High impedance; High impedance

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THERE WERE HIGH IMPEDANCES ON THE LEAD WHEN IT WAS INSERTED INTO THE INS. THE REP STATED THEY INSERTED THE LEAD INTO THE HEADER OF THE INS AND TOOK IMPEDANCES AND SAW > 40,000 OHMS ON CONTACTS 0, 4, 5, 10, 11, AND 15. THEY REMOVED THE LEAD TAILS, WIPED OFF THE LEAD AND REINSERTED INTO THE INS AND STILL SAW > 40,000. THEY TRIED INSERTING THE LEAD INTO THE WENS AND SAW BAD CONNECTIVITY ON (B)(6). THEY TRIED THIS AGAIN AND SAW THE SAME RESULTS. THE HCP MADE THE DECISION TO REPLACE THE LEAD. THE NEW LEAD SHOWED NORMAL IMPEDANCE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8166160 ↗
• MalfunctionJul 19, 2018Break; High impedance; Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER'S REPRESENTATIVE (REP) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR THE TREATMENT OF LUMBAR RADICULOPATHY AND SPINAL PAIN. IT WAS REPORTED THAT THE PATIENT WAS IN THE OPERATING ROOM AND THERE WERE HIGH IMPEDANCES NOTED. THE LEAD WAS RESET AND THE ISSUE WAS STILL PRESENT. THE REP STATED THAT THEY SUSPECTED THAT THE SET SCREW WAS NOT BACKED OUT ENOUGH ON THE INS AND MAY HAVE SCRAPED THE LEAD. A NEW LEAD WAS USED AND THE ISSUE RESOLVED. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7705411 ↗
• MalfunctionJul 17, 2018Difficult to Insert; Malposition of Device; Positioning Problem; Positioning Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR. IT WAS REPORTED THAT DURING THE PROCEDURE THE HEALTH CARE PROVIDER (HCP) TRIED FOR OVER 2 HOURS BUT WAS UNABLE TO PLACE THE LEAD PROPERLY. THE LEAD WAS OPENED BUT NOT USED AND THE HCP WANTED A DIFFERENT LEAD. X-RAY WAS USED AND THE ISSUE WAS RESOLVED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7693740 ↗
• InjuryJun 25, 2018High impedance; High impedance

  INFORMATION WAS RECEIVED FROM A MANUFACTURER¿S REPRESENTATIVE AND A HEALTHCARE PROFESSIONAL REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THERE WERE HIGH IMPEDANCES ON ELECTRODES 8, 9, 10, 13, 14, AND 15- THEY WERE GREATER THAN 20,000 OHMS WHEN THEY WERE CHECKED AT 1.5 VOLTS. THE PATIENT REPORTED NO ACCIDENTS OR FALLS AND DON'T KNOW WHAT COULD HAVE CAUSED THE HIGH IMPEDANCES. THE PATIENT WAS REPROGRAMMED USING ELECTRODES THAT WERE OK. THE ISSUE HAD NOT BEEN RESOLVED. SURGICAL INTERVENTION WAS NOT PLANNED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7634258 ↗
• MalfunctionSep 12, 2017Positioning Problem; Positioning Problem

  INFORMATION WAS RECEIVED FROM A COMPANY REPRESENTATIVE (REP) REGARDING A CONSUMER BEING IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT A LEAD WAS ATTEMPTED TO BE IMPLANTED, BUT WAS UNSUCCESSFUL AND SCRAPPED. IT WAS NOTED THAT THE ID CARD HAD AN INCORRECT SERIAL NUMBER. THE INS, PROGRAMMER, AND RECHARGER WERE NOT USED. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6858667 ↗
• InjurySep 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT THE HCP WAS MEETING WITH THE PATIENT FOR THE 2ND TIME AND THE PATIENT REPORTED THAT FOLLOWING THE IMPLANT OF THEIR SYSTEM, THEY BECAME PARALYZED AND THE LEAD WAS REMOVED THAT NIGHT OF IMPLANT. THE REP WAS SEEKING INFORMATION REGARDING AN MRI AS THE HCP WANTED TO DO AN MRI OF THE THORACIC SPINE. THE REP SAID THE CURRENT PLAN WAS BEING DISCUSSED AND THE HCP WAS TO GET SOME X-RAYS; IT WAS ALSO DISCUSSED TO HAVE THE INS REMOVED SO THEY COULD GET AN MRI, X-RAYS AND DO A POSSIBLE INTRATHECAL BACLOFEN TRIAL. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Ambulation or Postural Difficulties; Paralysis; Thrombosis; Vomiting

  MAUDE report 6850795 ↗

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