BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 1222417 · Received November 5, 2008

    Report

    Report Number
    3004209178-2008-07200
    Event Type
    Injury
    Date Received
    November 5, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 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
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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'S STIMULATION STOPPED WORKING. THE BATTERY APPEARED TO BE DEPLETED. WHEN THE STIMULATOR WAS REPLACED A LARGE DENT WAS NOTED IN THE BATTERY. THE PT HAD NOT FALLEN OR GONE SCUBA DIVING OR FLYING, THE REASON FOR THE DENT WAS UNK. IT WAS UNK IF THE DENT CONTRIBUTED TO EARLY BATTERY DEPLETION, OR IF THE DEPLETION WAS NORMAL END OF LIFE. THE PT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 7427 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention IMPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3487A| LEAD: MODEL 3487A| EXTENSION: MODEL 7489| EXPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 7435| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7489| IMPLANTED: