BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 1091607 · Received July 31, 2008

    Report

    Report Number
    1644487-2008-01751
    Event Type
    Injury
    Date Received
    July 31, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 1, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VNS PATIENT WAS EXPERIENCING AN INCREASE IN THE INTENSITY OF HIS SEIZURES. THE RELATIONSHIP OF THE INCREASE IN SEIZURES TO PRE-VNS BASELINE LEVELS IS UNKNOWN. THE PHYSICIAN ATTRIBUTED THE SEIZURE INCREASE TO BATTERY DEPLETION OF THE GENERATOR. HOWEVER, DIAGNOSTICS AND A BATTERY LIFE CALCULATION SHOWED THE GENERATOR HAD NOT REACHED END OF SERVICE YET. GENERATOR REVISION SURGERY WAS PERFORMED. THE EXPLANTED GENERATOR HAS BEEN RETURNED TO THE MFR AND IS UNDERGOING ANALYSIS. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention