BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1120743 · Received August 15, 2008

    Report

    Report Number
    1644487-2008-01925
    Event Type
    Injury
    Date Received
    August 15, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 18, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING GENERATOR REPLACEMENT SURGERY, A VNS PATIENT'S "ANCHOR" HAD LOOSENED, AND WOULD HAVE TO RETURN TO OR TO TIGHTEN THESE. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE. SURGERY TO CORRECT THE ISSUE IS LIKELY.

    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 Required Intervention