BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1892640 · Received November 3, 2010

    Report

    Report Number
    1644487-2010-02474
    Event Type
    Injury
    Date Received
    November 3, 2010
    Date of Event
    July 1, 2010
    Report Date
    October 5, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A PT'S FAMILY THAT THE VNS PT EXPERIENCED AN INCREASE IN DEPRESSION AND AGGRESSIVENESS. A BLC WAS PERFORMED AND INDICATED THE PT'S VNS WAS AT .52 YEARS UNTIL EOS=YES. THE PT'S FAMILY DECIDED TO REPLACE THE PT'S VNS PROPHYLACTICALLY DUE TO THE INCREASE IN DEPRESSION AND AGGRESSIVENESS AS THEY FELT IT WAS WELL CONTROLLED PREVIOUSLY WITH VNS. MOREOVER, THE PT'S FAMILY INDICATED THAT THEY HEAR A CLICKING NOISE COMING FROM THE GENERATOR AND NOT ASSOCIATED WITH STIMULATION. CURRENT SYSTEM DIAGNOSTICS WERE FINE, DCDC = 1, EOS = NO; NORMAL MODE DIAGNOSTICS WERE OKAY, DCDC = 4, EOS = NO. ADDITIONAL INFO WAS RECEIVED FROM A COMPANY REP INDICATING THE PT WAS STILL HEARING CLICKING NOISES FROM THE GENERATOR AND THE EVENT FIRST OCCURRED IN (B)(6) 2010. MOREOVER, MOTHER OF THE PT HAD ALSO REPORTED AN INCREASE IN SEIZURES (LEVEL WAS BELOW PRE-VNS BASELINE), AND THERE HAD ALSO BEEN AN INCREASE IN AGGRESSIVE BEHAVIOR WHICH HAD PREVIOUSLY BEEN UNDER CONTROL WITH VNS. 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 102 LYJ CYBERONICS, INC. 102

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention