BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2378444 · Received December 13, 2011

    Report

    Report Number
    1644487-2011-03058
    Event Type
    Injury
    Date Received
    December 13, 2011
    Date of Event
    October 1, 2011
    Report Date
    November 21, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 1

    CLINICAL NOTES DATED (B)(6) 2011 WERE RECEIVED BY THE MFR WHICH REVEALED THAT THE PT HAD TWO SEIZURES IN (B)(6) AND HAD FIVE SINCE THE PT'S LAST VISIT ON (B)(6) 2011. IT WAS REPORTED THAT THE PT'S SEIZURES ARE NOT WELL CONTROLLED. THE PT IS BEING REFERRED FOR PROPHYLACTIC GENERATOR REPLACEMENT. ALTHOUGH SURGERY IS LIKELY, IT HAS NOT OCCURRED TO DATE. ATTEMPTS FOR ADD'L INFO HAVE BEEN UNSUCCESSFUL TO DATE. A BATTERY LIFE CALCULATION WAS PERFORMED WITH THE HISTORY AVAILABLE IN THE MFR'S IN-HOUSE PROGRAMMING DATABASE, AND THE RESULTS WERE APPROX 3.22 YEARS UNTIL ERI=YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 010388

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male Required Intervention