BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1001048 · Received February 22, 2008

    Report

    Report Number
    1644487-2008-00378
    Event Type
    Injury
    Date Received
    February 22, 2008
    Date of Event
    January 1, 2008
    Report Date
    January 23, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT A VNS PT HAS EXPERIENCED "WOUND COMPLICATION" FOLLOWING IMPLANTATION. THE PT WAS REPORTED TO HAVE BEEN IN A LONG TERM CARE FACILITY IN AN ATTEMPT TO SAVE THE IMPLANTED PULSE GENERATOR. GOOD FAITH ATTEMPTS FOR ADDITIONAL INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization| R