BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2192436 · Received July 27, 2011

    Report

    Report Number
    1644487-2011-01699
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    February 3, 2011
    Report Date
    June 27, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED VIA CLINICAL NOTES RECEIVED TO THE MFR THAT A VNS PT HAD BREAKTHROUGH SEIZURES NOTED IN (B)(6) 2011, ALONG WITH STARING SPELLS AND EPISODES OF SHAKING. DILANTIN MEDICATION WAS INCREASED AND THE VNS OUTPUT CURRENT WAS INCREASED FROM 2.5MA TO 2.75MA AS INTERVENTIONS. IT WAS ALSO RECOMMENDED THE PT SWIPE THE VNS MAGNET PRIOR TO GOING TO SLEEP AT NIGHT AS A PREVENTIVE MEASURE. IT WAS ALSO DOCUMENTED THE PT'S SERUM AMMONIA WAS INCREASED. OVERALL, THE VNS HAS DECREASED THE PT'S SEIZURE FREQUENCY PER THE NOTES. THE PT IS SCHEDULED TO HAVE PROPHYLACTIC VNS GENERATOR REPLACEMENT ON (B)(6) 2011, BUT THIS HAS NOT BEEN CONFIRMED. ATTEMPTS FOR ADDITIONAL INFO ARE IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 7195

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention