BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1222010 · Received November 6, 2008

    Report

    Report Number
    3004209178-2008-07257
    Event Type
    Injury
    Date Received
    November 6, 2008
    Date of Event
    October 3, 2008
    Report Date
    October 10, 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
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WORKED WELL AFTER IMPLANTATION. THE PATIENT WAS ABLE TO RECHARGE THE STIMULATOR. THE PATIENT GAINED OVER THE SUMMER. THE STIMULATOR TURNED AROUND INSIDE THE TISSUE POCKET, EVEN THOUGH THE STIMULATOR HAD BEEN FIXED WITH TWO SUTURES. THE PATIENT HAD REVISION SURGERY DUE TO TILTING OF THE STIMULATOR IN THE DEVICE POCKET. AFTER REVISION SURGERY, THE PATIENT COMPLAINED THAT IT WAS ALMOST IMPOSSIBLE FOR HIM TO RECHARGE THE BATTERY. THE COUPLING BAR ON THE CHARGING DEVICE, WHICH INDICATES THE STRENGTH OF THE CHARGE, SHOWED 1-2 BARS OUT OF EIGHT. THEREFORE, THE PATIENT CHARGED THE DEVICE ALMOST CONTINUOUSLY WHILE IN A PRONE POSITION. THE RECHARGER SHUT OFF TWICE BECAUSE OF OVERHEATING. IN 2008, THE PATIENT WAS TAKEN BY AMBULANCE TO THE OUTPATIENT CLINIC AND PRESENTED WITH MASSIVE RED SKIN AND BUBBLING OVER THE SCAR OF THE STIMULATOR. THE PATIENT WAS TREATED WITH ANTIBIOTIC THERAPY (AVELOX) AND PARKEMED. THE PATIENT WAS SEEN AGAIN THREE DAYS LATER. THE INFLAMMATION HAD DECREASED; THE PATIENT'S SKIN HAD IMPROVED. THE PATIENT CONTINUED TREATMENT WITH ANTIBIOTIC OINTMENTS. THE PATIENT WAS ABLE TO OBTAIN 5 BARS ON THE CHARGING INDICATOR. THE PATIENT WAS SEEN FOUR DAYS LATER. THE INFLAMMATION CONTINUED TO DECREASE. COMPLETE CHARGING OF THE BATTERY WAS POSSIBLE WITHIN 1-2 HOURS. THE PATIENT CONTINUED TO USE ANTIBIOTIC OINTMENT. THE PATIENT FULLY CHARGES THE STIMULATOR EVERY SECOND DAY FOR 1-2 HOURS. THE PATIENT'S THERAPY WAS WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED RECHARGEABLE LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LEAD: MODEL 3487A| IMPLANTED:| RECHARGER: MODEL UNK| EXPLANTED:| IMPLANTED:| EXLPANTED:| LEAD: MODEL 3888