BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1943829 · Received December 28, 2010

    Report

    Report Number
    1644487-2010-02905
    Event Type
    Injury
    Date Received
    December 28, 2010
    Date of Event
    November 1, 2010
    Report Date
    December 8, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THROUGH PT CLINIC NOTES THAT THE PT WAS HAVING SOME INCREASE IN SEIZURES AND THE PHYSICIAN FELT THAT THESE WERE SIGNS OF CLINICAL SYMPTOMS OF APPROACHING VNS END OF SERVICE BATTERY. PATIENT'S DIAGNOSTICS RESULTS SHOWED EVERYTHING WORKING WITHIN NORMAL LIMITS WITH GENERATOR NOT AT END OF SERVICE; HOWEVER, THE PHYSICIAN FELT THAT THE BATTERY WAS APPROACHING END OF SERVICE AND NEEDS REPLACEMENT. PT WAS REFERRED TO THE SURGEON FOR A BATTERY REPLACEMENT SURGERY. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO HAS BEEN UNSUCCESSFUL TILL DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 011537

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention