BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 1905375 · Received November 18, 2010

    Report

    Report Number
    1644487-2010-02603
    Event Type
    Injury
    Date Received
    November 18, 2010
    Date of Event
    January 1, 2005
    Report Date
    October 19, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF THE MANUFACTURING RECORDS CONFIRMED STERILIZATION FOR BOTH THE GENERATOR AND LEAD PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PT'S DEVICE WAS EXPLANTED DUE TO UNK REASONS. THE NEUROLOGIST INDICATED THAT THE PULSE GENERATOR WAS REMOVED DUE TO A BELIEVED INFECTION AT SOME POINT IN 2005, BUT NO FURTHER SPECIFICS WERE MADE AVAILABLE ON THE EVENT. A REVIEW OF THE MANUFACTURER DEVICE HISTORY RECORDS INDICATE THAT BOTH THE LEAD AND PULSE GENERATOR WERE STERILIZED PRIOR TO DISTRIBUTION. 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 101 LYJ CYBERONICS, INC. 101 7380

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention