BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1920014 · Received December 3, 2010

    Report

    Report Number
    1644487-2010-02729
    Event Type
    Injury
    Date Received
    December 3, 2010
    Date of Event
    January 1, 2010
    Report Date
    November 3, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD BREAKTHROUGH SEIZURES RECENTLY AND THE PHYSICIAN SUSPECTS THE GENERATOR MAY BE NEARING EOS. A ROUGH BATTERY LIFE CALCULATION WAS PERFORMED WHICH RESULTED IN APPROXIMATELY 1.6 YEARS REMAINING UNTIL ERI = YES. ATTEMPTS FOR FURTHER 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 009342

    Patients

    Seq Age Sex Outcome Treatment
    1 Other