BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 3092864 · Received May 3, 2013

    Report

    Report Number
    1644487-2013-01239
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    January 15, 2013
    Report Date
    April 9, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. X-RAYS REVIEWED BY THE MANUFACTURER, NO GROSS LEAD DISCONTINUITIES VISUALIZED. NO ISSUES WERE NOTED VIA X-RAY REVIEW SUGGESTING A DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    REPORTER INDICATED A PATIENT WAS HAVING WORSENING TONIC SEIZURES AND VOMITING THAT ARE FELT TO BE DUE TO VNS STIMULATION AND VNS SURGERY. THE PATIENT HAD NO TRAUMA AND DOES NOT MANIPULATE THE VNS. THE INTERVENTION FOR THE EVENTS WAS TO CHANGE THE VNS MAGNET PULSEWIDTH SETTING FROM 500 TO 250. THE LAST KNOWN SETTINGS WERE 2 MA/30HZ/500'S/30SEC/1.1MIN AND MAGNET MODE WAS 2.25MA/60SEC/250'S.ATTEMPTS FOR ADDITIONAL INFORMATION ARE IN PROGRESS.

    Description of Event or Problem · 1

    X-RAYS WERE RECEIVED AND REVIEWED BY THE MANUFACTURER. THE GENERATOR APPEARS IN THE UPPER LEFT CHEST IN A NORMAL PLACEMENT. THE FILTER FEED-THROUGH WIRES APPEARED TO BE INTACT. THE LEAD CONNECTOR PIN INSERTION INTO THE GENERATOR CONNECTOR BLOCK COULD NOT BE ASSESSED. THE ELECTRODES APPEARED TO BE PLACED IN NORMAL ARRANGEMENT. PART OF THE LEAD WAS BEHIND THE GENERATOR. NO ACUTE ANGLE WAS FOUND AND NO LEAD BREAK WAS VISIBLE IN THE LEAD BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195115 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS INC 103 202296

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Other