BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3298809 · Received August 20, 2013

    Report

    Report Number
    3004209178-2013-14881
    Event Type
    Injury
    Date Received
    August 20, 2013
    Report Date
    July 29, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37754, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE RECHARGER; PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 3888-33, LOT# V821945, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3888-33, LOT# V885492, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF NEUROSTIMULATOR MODEL 37714, SERIAL # (B)(4) SHOWED THE BATTERY HAD A REDUCED CAPACITY TO OVERDISCHARGE CONDITION. THE STIMULATOR WAS RECEIVED WITH NO TELEMETRY. THE DEVICE RECOVERED NORMALLY FOR TESTING AFTER A PHYSICIAN MODE RECHARGE (PMR) PROCEDURE. PER THE TRACE REPORT THE TOTAL RECHARGE COUNT FOR THE DEVICE WAS 32 WITH THE LAST RECORDED RECHARGE SESSION, WHILE THE DEVICE WAS IMPLANTED, DATE OF (B)(6) 2013. DURING THAT SESSION, THE DEVICE WAS RECHARGED FOR A TOTAL OF 1 HOUR 43 MINUTES AND THE BATTERY CHARGED FROM 2.965 TO 3.715 VOLTS. THE BATTERY DISCHARGED TO THE LOCK MODE ON (B)(6) 2013. THE DEVICE WAS FIRST TESTED (FUNCTIONAL TEST) WITH THE ADAPTIVE STIMULATION FEATURE ENABLED AND FAILED. THE FEATURE WAS THEN DISABLED AND THE DEVICE RETESTED AND PASSED THE FINAL FUNCTIONAL TEST. GOOD, S TABLE OUTPUT WAS THEN SEEN ON ALL ELECTRODES REFERENCED TO ONE ELECTRODE. ANALYSIS OF LEAD MODEL 3778-60, SERIAL# (B)(4) SHOWED NO SIGNIFICANT ANOMALIES.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE STIMULATION WAS ON WRONG SIDE AND IN ABDOMEN. X-RAY DID NOT SHOW MIGRATION. THE PATIENT HAD BEEN REPROGRAMMED. THE PHYSICIAN PLANS TO REVISE EPIDURAL LEAD TO PROVIDE BETTER COVERAGE TO CORRECT SIDE. LESS THAN TWO WEEKS LATER IT WAS REPORTED THAT THE REVISION HAD TAKEN PLACE. IT WAS STATED THAT THE PATIENT WAS TO BE SEEN POST REVISION ONE DAY AFTER THE REPORT. ONE DAY LATER IT WAS REPORTED THAT THE PATIENT DID NOT CHARGE THE DEVICE FOR THE POST REVISION APPOINTMENT AND THE PROGRAMMING WOULD BE ATTEMPTED ONE WEEK AFTER THE REPORT AFTER SHE CHARGED. IT WAS REPORTED THAT THE PATIENT MET WITH A COMPANY REPRESENTATIVE IN THE CLINIC AND SHE DID NOT HAVE STIMULATION WHERE SHE NEEDED IT. IT WAS NOTED THAT THE IMPEDANCES WERE "WITHIN NORMAL LIMITS". THE PATIENT WAS REQUESTING AN EXPLANT. IT WAS ALSO NOTED THAT THE PATIENT "WAS NEVER COMPLIANT WITH USAGE OR CHARGING POST IMPLANTATION. IT WAS REPORTED THE DEVICE WAS EXPLANTED DUE TO PATIENT NON-COMPLIANCE. IT WAS NOTED IT WAS NOT REMOVED DUE TO NORMAL BATTERY DEPLETION. IT WAS NOTED THE PATIENT RECOVERED WITHOUT SEQUELA. (B)(6) 2013 (B)(4) UPDATE (REP): ADDITIONAL INFORMATION NOTED THE THERAPY WAS UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401834 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention