BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 1111636 · Received August 13, 2008

    Report

    Report Number
    3004209178-2008-04916
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    July 5, 2008
    Report Date
    July 15, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IMPEDANCES ON ALL OR SOME OF THE BIPOLAR PAIRS WERE GREATER THAN 4000 OHMS. ALL OTHER IMPEDANCES WERE 932. THE PT HAD RELIEF FROM THERAPY. THE DEVICE AMPLITUDE HAD BEEN SET AT 10.5 VOLTS AT TIMES. THE BATTERY MEASURED 2.56 VOLTS. DEVICE LONGEVITY WAS ESTIMATED AT 34 MONTHS BASED ON THERAPY MEASUREMENT OF 1000 OHMS. THE DEVICE HAD BEEN IMPLANTED FOR 36 MONTHS". 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 LEAD MODEL 3998| EXPLANTED| EXTENSION MODEL 7489| EXPLANTED| EXPLANTED| EXTENSION MODEL 7489