BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1060001 · Received June 10, 2008

    Report

    Report Number
    1644487-2008-01344
    Event Type
    Malfunction
    Date Received
    June 10, 2008
    Date of Event
    May 13, 2008
    Report Date
    May 13, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    REPORTER INDICATED A VNS PT WAS UNABLE TO BE INTERROGATED. THE PT WAS RECENTLY IMPLANTED WITH THE VNS AND VNS DIAGNOSTICS WERE NORMAL DURING THE SURGERY. INTERROGATION OF THE PT'S VNS WAS ALSO UNSUCCESSFUL BY THE MFR AT AN OFFICE VISIT. A SURGERY CONSULT IS PLANNED FOR 2008. THE PT ALSO HAS A PACEMAKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 1972

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR