BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 1241165 · Received November 20, 2008

    Report

    Report Number
    1644487-2008-02822
    Event Type
    Injury
    Date Received
    November 20, 2008
    Date of Event
    October 21, 2008
    Report Date
    October 21, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. X-RAYS REVIEWED BY THE MANUFACTURER, NO GROSS LEAD DISCONTINUITIES VISUALIZED.

    Description of Event or Problem · 1

    REPORTER INDICATED A VNS THERAPY PATIENT WAS HAVING PAIN WITH STIMULATION, WHICH RESOLVED WHEN THE GENERATOR WAS TURNED OFF. THE TREATING PHYSICIAN WAS NOT ABLE TO DO A SYSTEM TEST BECAUSE THE PATIENT COULD NOT EVEN TOLERATE THE SLIGHTEST AMOUNT OF STIMULATION AND WOULD NOT BE STILL DURING THE TEST. THE PHYSICIAN REVIEWED X-RAYS AND NO OBVIOUS LEAD BREAKS WERE IDENTIFIED. THE X-RAYS WERE SENT TO THE MANUFACTURER FOR REVIEW. NO ANOMALIES WERE IDENTIFIED. THE PATIENT BROUGHT IN FOR SURGERY AND WAS ANESTHETIZED AND PRIOR TO BEGINNING THE SURGERY, THE PHYSICIAN PERFORMED TWO SYSTEMS DIAGNOSTIC AND ONE NORMAL MODE DIAGNOSTIC TEST, AND ALL WERE WITHIN NORMAL LIMITS. THE PHYSICIAN REMOVED THE LEAD PIN FROM THE GENERATOR AND THEN REINSERTED IT. AGAIN, DIAGNOSTICS WERE NORMAL. THE GENERATOR WAS NOT REPLACED. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 LYJ CYBERONICS, INC. 103 200882

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Other