BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1212658 · Received October 24, 2008

    Report

    Report Number
    1644487-2008-02578
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    September 18, 2008
    Report Date
    September 25, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: MFR REVIEWED X-RAYS OF IMPLANTED DEVICE. ELECTRODES NOT ORIENTED ACCORDING TO WHAT IS TYPICALLY VIEWED. STRAIN RELIEF APPEARED TO BE INADEQUATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD HER VNS DEVICE TURNED OFF FOR THREE WEEKS, AND WHEN THE DEVICE WAS TURNED BACK ON, SHE BEGAN EXPERIENCING PAIN/BURNING SENSATIONS AT THE CHEST SITE. SHE ALSO EXPERIENCED EXTREME SHORTNESS OF BREATH DURING SYSTEM DIAGNOSTICS TEST AND MAGNET USE. DIAGNOSTIC TESTS SHOWED VNS TO BE FUNCTIONING PROPERLY. THE PT'S DEVICE WAS PROGRAMMED OFF. X-RAYS WERE SENT TO THE MFR FOR REVIEW. THE NEGATIVE ELECTRODE DID NOT APPEAR TO BE IN THE TYPICAL HELICAL ORIENTATION. ADDITIONALLY, THE ELECTRODES WERE NOT ALIGNED VERTICALLY. THE STRAIN RELIEF OF THE LEAD BODY AT THE NECK DID NOT APPEAR TO BE ADEQUATE. NO TIE-DOWNS WERE VISUALIZED. NO OBVIOUS LEAD DISCONTINUITIES WERE OBSERVED. THE PT HAS CURRENTLY BEEN REFERRED FOR A SURGICAL CONSULT. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention