BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1102490 · Received August 8, 2008

    Report

    Report Number
    1644487-2008-01804
    Event Type
    Injury
    Date Received
    August 8, 2008
    Date of Event
    January 1, 2008
    Report Date
    July 10, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO MANUFACTURER THAT THE VNS PATIENT HAS BEEN EXPERIENCING LOCAL PAIN DUE TO A SCAR FROM THE VNS IMPLANTATION SURGERY. HOSPITALIZATION WAS PLANNED TO EXAMINE THE SCAR BY NEUROSURGEON. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL REGARDING REPORTED EVENTS HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 PULSE GENERATOR LYJ CYBERONICS, INC. 102 200616

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization