BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 1153093 · Received September 8, 2008

    Report

    Report Number
    3004209178-2008-05527
    Event Type
    Injury
    Date Received
    September 8, 2008
    Date of Event
    August 2, 2008
    Report Date
    August 8, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.,
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS EXPERIENCING SEVERE PAIN IN BOTH FEET FROM HIS ORIGINAL NEUROPATHY. HE ALSO EXPERIENCED PAINFUL RANDOM ELECTRICAL IMPULSES FROM THE SPINAL CORD STIMULATOR. AT THE SAME TIME THAT THE PAINFUL STIMULATION BEGAN, HE BEGAN TO SUFFER FROM "A COMPLETE BREAKDOWN OF BOTH LONG AND SHORT-TERM MEMORY IN ADDITION TO RECALLING MEMORIES OF THINGS THAT NEVER OCCURRED." THE PT CAREGIVER CONTACTED THE PRIMARY CARE PHYSICIAN WITH CONCERNS REGARDING "SHORT AND LONG TERM MEMORY LOSS, SEIZURES, POSSIBLE CONCUSSION, AND STIMULATOR FAILURE". THE HEALTH PROVIDER RECOMMENDED A VISIT TO THE EMERGENCY ROOM TO OBTAIN IMAGES OF HIS HEAD WOUND AND POSSIBLE CONCUSSION SITE. THE CIRCUMSTANCES AND DETAILS REGARDING THE HEAD INJURY AND SEIZURE WERE NOT SPECIFIED. THE COMPANY REP EVALUATED THE DEVICE ON 8/8/2008 FOR COMPLAINT OF "SHOCKING" AND "ELECTROCUTION". THE NEUROSTIMULATOR WAS INTERROGATED AND ALL PARAMETERS WERE NORMAL. THE BATTERY STATUS WAS OK. IMPEDANCES FOR ALL 16 ELECTRODES WERE IN THE 700 RANGE (NORMAL VALUES). THE A1 PROGRAM WAS STILL CONFIGURED AT THE LOWER ELECTRODES FOR COVERAGE OF HIS FEET. THE A2 PROGRAM WAS STILL CONFIGURED AT THE LEAD'S UPPER ELECTRODES. THERE WERE NO OTHER PROGRAMS ACTIVATED. HIS USEABLE AMPLITUDE RANGE WAS FROM ABOUT 0.7 TO ABOUT 1.2 VOLTS, LOW TO HIGH THRESHOLDS. NO CURRENT REGISTERED ACROSS THE ELECTRODES AT 0.1 AND 0.2 VOLTS. AT 0.3 VOLTS THE CURRENT REGISTERED AT ABOUT 2MA, AT 0.45 VOLTS, THE CURRENT REGISTERED AT ABOUT 5MA; THERE IS APPROPRIATE CURRENT FLOW AT THE ELECTRODES. AT 0.45V LEVEL, EVENT THOUGH IT WAS BELOW HIS LOW THRESHOLD POINT OF 0.7V, THE PT EXPRESSED THAT HE WAS FEELING PAIN RELIEF IN HIS FEET. THE PT WAS APPREHENSIVE ABOUT TURNING IT UP MUCH HIGHER SO THEY ONLY WENT TO 0.6V DURING THE EVAL. THE COMPANY REP ASKED HIM TO MOVE TO A VARIETY OF POSITIONS TO SEE IF HE COULD PERCEIVE ANY OF THE USUAL INTENSITY VARIATIONS CAUSED BY NORMAL SPINAL CORD MOVEMENT RELATIVE TO THE LEAD'S POSITION, AND HE FELT NONE. THE PT'S PROGRAMMER WAS WORKING APPROPRIATELY. TIME WAS SPENT VERIFYING CORRECT OPERATION OF THE PT PROGRAMMER BY THE PT AND THE CAREGIVER. NO ASPECT OF HIS SYSTEM WAS FOUND THAT WOULD CAUSE UNDUE STRENGTH OF THE STIMULATION ON THE SPINAL CORD IF IT IS SET APPROPRIATELY LOW. THE PT STATED EXCELLENT PAIN RELIEF IN FEET AND SECONDARY BACK PAIN. ADD'L INFO HAS BEEN REQUESTED FROM THE HEALTH PROVIDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE RECHARGEABLE NEUROSTIMULATOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO., 37711 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED| EXPLANTED| EXTENSION MODEL 37081 LOT# NJB036441V| IMPLANTED| IMPLANTED| LEAD MODEL 39565 LOT# N153624002| IMPLANTED| RECHARGER SYSTEM MODEL 37752 LOT# NKA114096N| EXTENSION MODEL 37081 LOT# NJB036117V| EXPLANTED| PROGRAMMER MODEL 37743 LOT# NKE104534N