BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 1222865 · Received November 6, 2008

    Report

    Report Number
    3004209178-2008-07240
    Event Type
    Malfunction
    Date Received
    November 6, 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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT LOST STIMULATION SENSATION FOLLOWING EXPOSURE TO A THEFT DETECTOR/SECURITY GATE AT A NATIONAL SECURITY OFFICE. THE DEVICE WAS ON AT THE TIME OF THE EVENT. THE PATIENT REMAINS AT HOME IN GOOD STATUS. THE DATE OF THE EXPOSURE WAS NOT REPORTED. THE PATIENT HAS TWO DIFFERENT STIMULATORS IMPLANTED. IT IS UNKNOWN WHICH DEVICE, OR BOTH, WERE AFFECTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SEE ALSO MFR REPORT #3004209178200807239.

    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 EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 7495-25| LEAD: MODEL 3487A| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3887| EXPLANTED:| LEAD: MODEL 3888| IMPLANTED:| LOT# NAT153916H| IMPLANTABLE NEURO STIMULATOR: MODEL 7425| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7495-10| EXPLANTED:| EXTENSION: MODEL 7495-51| IMPLANTED:| EXPLANTED: