BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 1170705 · Received September 16, 2008

    Report

    Report Number
    3004209178-2008-05807
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Date of Event
    August 19, 2008
    Report Date
    August 19, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION WHEN SITTING IN A CHAIR. FOLLOWING THE JOLT, WHEN THE PATIENT TURNED OFF HER STIMULATION, SHE WAS THEN UNABLE TO TURN THE STIMULATION BACK ON. THE MANUFACTURER'S REPRESENTATIVE WAS ALSO UNABLE TO GET THE PATIENT TO FEEL ANY STIMULATION. THE DEVICE BATTERY READ LESS THAN 20% WAS USED. THE SETTINGS REFLECTED A LONGEVITY CALCULATION OF GREATER THAN 120 MONTHS FROM THE DATE OF THE IMPLANT. NO OTHER SYMPTOMS OR OUTCOME WERE REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.

    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 72 YR Required Intervention EXTENSION MODEL 7489| EXPLANTED:| IMPLANTED:| LEAD MODEL 3487A| IMPLANTED:| EXTENSION MODEL 7489| EXPLANTED:| IMPLANTED:| EXPLANTED: