BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED RECHARGABLE

    MDR report key: 1082991 · Received July 28, 2008

    Report

    Report Number
    3004209178-2008-04461
    Event Type
    Injury
    Date Received
    July 28, 2008
    Date of Event
    January 1, 2008
    Report Date
    June 30, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE NEUROSTIMULATOR, LEAD, EXTENSION, AND AN ACCESSORY (PLUG) WERE RETURNED FOR ANALYSIS. ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED DEVICE WARMING AT THE BATTERY SITE. WHEN STIMULATION WAS TURNED ON, THE SKIN OVER THE NEUROSTIMULATOR WAS WARM TO THE TOUCH AND SLIGHTLY FLUSHED. THE STIMULATION COULD BE ON FOR SEVERAL HOURS, BUT THEN THE WARMING BECAME UNCOMFORTABLE AND THE PT HAD TO TURN THE STIMULATION OFF. THE PT WAS RUNNING TWO PROGRAMS: 1.5V AND 3.8V. SEVERAL THINGS INCLUDING CYCLING PROGRAMS AND REVISION WERE TRIED. NOTHING WAS SUCCESSFUL AT RESOLVING THE WARM SENSATION. THE SYSTEM WAS EXPLANTED. NO PT OUTCOME WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ACCESSORY MODEL 37752 LOT# NKA031484N| IMPLANTED| IMPLANTED| PROGRAMMER MODEL 37742 LOT# NJD061352N| STIM ACCESSORY (PLUG) MODEL UNK LOT # UNK| EXPLANTED| LEAD MODEL 3777 LOT# V072746026| IMPLANTED| EXPLANTED| EXTENSION MODEL 37081 LOT# NJB007250V| EXPLANTED