BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY COMPACT PLUS

    MDR report key: 1030967 · Received April 17, 2008

    Report

    Report Number
    3004209178-2008-02032
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Date of Event
    March 1, 2008
    Report Date
    March 17, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001/S77
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WITH A SYNERGY STIMULATOR HAD A LOSS OF THERAPEUTIC EFFECT. IT WAS ALSO REPORTED THAT THE PATIENT FELT A SURGING SENSATION WHILE GOING THROUGH A SECURITY GATE. FURTHER INFORMATION IS BEING REQUESTED FROM THE HCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY COMPACT PLUS LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 7479B NA

    Patients

    Seq Age Sex Outcome Treatment
    1 EXPLANTED| EXPLANTED| LEAD MODEL 3093 LOT# V010004| IMPLANTED| IMPLANTED| LEAD MODEL 3093 LOT# V009811| IMPLANTED| IMPLANTED| EXPLANTED| EXTENSION MODEL 3095 LOT# NAH032107V| EXTENSION MODEL 3095 LOT# NAH032108V| EXPLANTED