BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 1213072 · Received October 23, 2008

    Report

    Report Number
    3004209178-2008-06843
    Event Type
    Malfunction
    Date Received
    October 23, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 25, 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
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT AND NO STIMULATION TWO WEEKS POST OPERATIVELY. THE AMPLITUDE WAS INCREASED TO 10.5 VOLTS ON ELECTRODES 0-3 AND THE PATIENT DID NOT FEEL STIMULATION. SOME ELECTRODE IMPEDANCES WERE GREATER THAN 4000 OHMS WHEN MEASURED AT 1.5 VOLTS. ELECTRODES IMPEDANCES WERE LESS THAN 4000 OHMS WHEN THE AMPLITUDE WAS INCREASED TO 4 VOLTS. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION 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 56 YR LEAD: MODEL 3487A| EXPLANTED:| LEAD: MODEL 3487A| EXTENSION: MODEL 7495LZ| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 7435| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7495LZ| EXPLANTED:| IMPLANTED:| IMPLANTED: