BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2192457 · Received July 27, 2011

    Report

    Report Number
    1644487-2011-01712
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    June 27, 2011
    Report Date
    June 27, 2011
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FURTHER INFORMATION REVEALS THAT THE EXPLANTED DEVICE WAS DISCARDED AND CANNOT BE RETURNED TO THE MANUFACTURER FOR ANALYSIS. NO FURTHER INFORMATION IS AVAILABLE REGARDING EVENT.

    Description of Event or Problem · 1

    ANALYSIS WAS COMPLETED ON THE RETURNED GENERATOR AND IT WAS FOUND TO BE AT EXPECTED END OF SERVICE. THEREFORE, IT IS LIKELY THAT THE INCREASED SEIZURES WERE DUE TO EXPECTED END OF SERVICE AS INITIALLY REPORTED.

    Description of Event or Problem · 1

    FURTHER INFORMATION REVEALS THAT THE DEVICE IS AVAILABLE FOR RETURN TO MANUFACTURER. EXPLANTED GENERATOR WAS RETURNED TO THE MANUFACTURER, BUT ANALYSIS IS PENDING. INFORMATION FROM PHYSICIAN ALSO CLARIFIED THAT THE BELIEVED CAUSE OF THE SEIZURES WAS CLINICAL END OF SERVICE AND THE GENERATOR WAS CHANGED PROPHYLACTICALLY. THE PHYSICIAN DOES NOT ALWAYS TRUST THE ERI FLAG AND WILL CHANGE THE GENERATOR IF SEIZURES INCREASE AS A GENERAL POLICY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS HOSPITALIZED FOR INCREASED SEIZURES AND THE PHYSICIAN WAS UNABLE TO INTERROGATE THE GENERATOR. IT IS UNK IF THE SEIZURES ARE ABOVE OR BELOW PRE-VNS BASELINE. REPORTER STATES PT'S INCREASE IN SEIZURES IS LIKELY DUE TO GENERATOR END OF SERVICE, BUT THIS IS NOT CONFIRMED. THE PT UNDERWENT GENERATOR REPLACEMENT SURGERY. ATTEMPTS FOR FURTHER INFO AND PRODUCT RETURN 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 010324

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Hospitalization| R