BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1052245 · Received May 23, 2008

    Report

    Report Number
    1644487-2008-01211
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Date of Event
    April 23, 2008
    Report Date
    April 25, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 THAT AN EXPLANTED VNS GENERATOR WAS NOT AT END OF SERVICE, BUT "HAD NOTHING LEFT" AND FELT THERE WAS A PROBLEM WITH THE GENERATOR. A BATTERY ESTIMATE PERFORMED WITH LIMITED PROGRAMMING HISTORY SHOWED -2.10 YEARS REMAINING, INDICATING POSSIBLE END OF SERVICE. THE EXPLANTED GENERATOR HAS BEEN RETURNED AND IS CURRENTLY IN PRODUCT ANALYSIS. ATTEMPTS FOR ADDITIONAL INFO IS IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 7272

    Patients

    Seq Age Sex Outcome Treatment
    1