BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2191125 · Received July 29, 2011

    Report

    Report Number
    1644487-2011-01729
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    March 21, 2011
    Report Date
    June 30, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT WAS HAVING AN INCREASE IN SEIZURES, UNKNOWN IF ABOVE OR BELOW BASELINE. THE PATIENT HAD A PROPHYLACTIC GENERATOR REPLACEMENT. PRODUCT RETURN ATTEMPTS ARE IN PROCESS. GOOD FAITH ATTEMPTS FOR MORE INFORMATION 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 010024

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention