BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNS THERAPY PULSE

    MDR report key: 449716 · Received March 20, 2003

    Report

    Report Number
    1644487-2003-00136
    Event Type
    Injury
    Date Received
    March 20, 2003
    Date of Event
    February 1, 2003
    Report Date
    February 21, 2003
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT PT'S HEART RATE HAS INCREASED FROM 88-112 BEATS/MIN TO 120-124 BEATS/MIN. THE PT'S DEVICE WAS PROGRAMMED TO ON THE SAME DAY OF IMPLANT SURGERY TO THE LOWEST NORMAL MODE OUTPUT CURRENT (0.25MA). TREATING NEUROLOGIST INDICATED THAT THERE IS NO CLEAR REASON FOR THE EVENT, BUT THAT IT WAS DOUBTFUL THAT IT WAS RELATED TO THE VNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VNS THERAPY PULSE PULSE GENERATOR LYJ CYBERONICS, INC. 102 7469

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Life Threatening LOT NO. 6267.| CLONAZEPAM (OT, QH), LEVETIRACETAM (500, 4 BID).| CURRENT MEDICATIONS: LAMOTRIGINE (100, 2 1/2 BIB),| MODEL 302-20 VNS THERAPY LEAD, EXPIR DATE| 6/30/2004, DATE OF MFG 4/25/2002, STERILIZATION