BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1060003 · Received June 10, 2008

    Report

    Report Number
    1644487-2008-01345
    Event Type
    Malfunction
    Date Received
    June 10, 2008
    Date of Event
    January 1, 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
    UK
    Reporter Occupation
    PHYSICIAN

    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 THAT A PT'S VNS GENERATOR WAS AT PREMATURE END OF SVC. THE END OF SVC FLAG WAS SET TO YES, BUT THE PT WAS ON MODERATE SETTINGS AND THE END OF SVC WAS AN UNEXPECTED EVENT. THE PT DOES FEEL SOME RANDOM STIMULATION. A BATTERY ESTIMATE DONE WITH INCOMPLETE PROGRAMMING HISTORY YIELDED 7.11 YRS REMAINING. GENERATOR REPLACEMENT IS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 012081

    Patients

    Seq Age Sex Outcome Treatment
    1