BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 1053227 · Received May 28, 2008

    Report

    Report Number
    3004209178-2008-02843
    Event Type
    Malfunction
    Date Received
    May 28, 2008
    Date of Event
    April 1, 2008
    Report Date
    April 28, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN 2008, THE BATTERY STATUS WAS DEEMED AT END-OF-SERVICE LIFE, REVISION WAS PENDING FOR INSURANCE REASONS. SUBSEQUENTLY THERE WAS INTERACTION WITH SECURITY THEFT DETECTOR DEVICES; THE DEPLETED BATTERY HAD CAUSED THEFT DETECTOR DEVICES TO ALARM. THERE WERE NO PT SYMPTOMS OR INJURY REPORTED. ADD'L INFO HAS BEEN REQUESTED FROM THE PHYSICIAN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 EXTENSION MODEL 7489 LOT# NHU106733V| IMPLANTED| EXPANTED| LEAD MODEL 3487A LOT# V045796| IMPLANTED| EXPLANTED| EXTENSION MODEL 7489 LOT# NHU069264V| EXPLANTED| IMPLANTED| IMPLANTED| LEAD MODEL 3487A LOT# V045796| EXPLANTED