BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 4173832 · Received October 15, 2014

    Report

    Report Number
    1644487-2014-02695
    Event Type
    Injury
    Date Received
    October 15, 2014
    Date of Event
    July 31, 2013
    Report Date
    September 19, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE VNS PATIENT UNDERWENT KELOID SCAR REMOVAL SURGERY BUT WAS UNABLE TO STIMULATION ON-TIMES FROM HER DEVICE FOLLOWING THE PROCEDURE. ATTEMPTS FOR ADDITIONAL RELEVANT INFORMATION WILL BE MADE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT WAS EXPECTED TO UNDERGO KELOID REMOVAL SURGERY THAT HAD FORMED FROM HER PREVIOUS SURGERY AND CAUSING PAIN. NO KNOWN SURGICAL INTERVENTIONS HAVE OCCURRED TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE VNS PATIENT¿S DEVICE WAS TESTED AND SYSTEM DIAGNOSTIC RESULTS REVEALED LEAD IMPEDANCE WITHIN NORMAL LIMITS. IT WAS NOTED THAT THE PATIENT COUGHED WHEN THE DEVICE FREQUENCY WAS INCREASED TO 30HZ. THE DEVICE FREQUENCY WAS SUBSEQUENTLY REDUCED BACK TO THE PREVIOUS SETTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656154 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 202436

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention