BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2161859 · Received July 8, 2011

    Report

    Report Number
    1644487-2011-01499
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    January 1, 2007
    Report Date
    June 9, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED IN A PT'S CLINIC NOTES THAT THE PT WOULD LIKE TO HAVE HIS VNS BATTERY REMOVED. THE PT RECENTLY RAN THE MAGNET OVER THE DEVICE AND FELT NO DISCHARGE, BUT THE BATTERY HAD BEEN TURNED OFF, WHICH HAD BEEN CONFIRMED BY PREVIOUS INTERROGATIONS. THE DEVICE HAD BEEN DISABLED AS IT LED TO "VOICE CHANGES AND BLOOD COUGH". THE PT HAD INITIALLY TOLERATED THE VNS "RATHER WELL OUTSIDE OF SOME VOICE CHANGES. HOWEVER, GIVEN HIS SEIZURE FREQUENCY AT SOME TIME IN THE PAST, HE RAMPED UP THE SETTINGS WHICH CAUSED HIM TO HAVE SOME HEMOPTYSIS". THE PT DID BELIEVE THE VNS TO HAVE HELPED HIS SEIZURE FREQUENCY, AND THE PHYSICIAN ADMITTED THE SEIZURE FREQUENCY HAD BEEN LOWERED WHILE ON THE THERAPY. A REVIEW OF THE PT'S PROGRAMMING HISTORY REVEALED LAST KNOWN SETTINGS AND DIAGNOSTICS FROM (B)(6) 2008. THE DEVICE WAS PROPERLY FUNCTIONING AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 009946

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention