BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 1133625 · Received August 20, 2008

    Report

    Report Number
    3004209178-2008-05099
    Event Type
    Malfunction
    Date Received
    August 20, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 22, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED IMPEDANCE READINGS WERE >4000 OHMS ON SOME/ALL BIPOLAR PAIRS. THE PATIENT DID NOT REPORT ANY SYMPTOMS; SHE NOTED THAT SHE HAD A SEVER FALL SEVERAL YEARS AGO. THE PATIENT HAS NOT USED HER STIMULATION CONSISTENTLY. THE PATIENT HAS CONSIDERED SYSTEM REPLACEMENT. NO OUTCOME WAS REPORTED. 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 Required Intervention LEAD MODEL 3587A LOT# LA1388| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| EXTENSION MODEL 7495-51 LOT#XR0056349N