BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2241414 · Received August 18, 2011

    Report

    Report Number
    1644487-2011-01901
    Event Type
    Malfunction
    Date Received
    August 18, 2011
    Date of Event
    July 21, 2011
    Report Date
    July 21, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF MANUFACTURING RECORDS CONFIRMED THAT THE DEVICE MET SPECIFICATIONS AND NO ANOMALIES WERE OBSERVED PRIOR TO THE DEVICE LEAVING THE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A SURGEON THAT DURING REPOSITION SURGERY OF A VNS GENERATOR, HE WAS NOT ABLE TO REMOVE THE LEAD FROM THE GENERATOR. THE PHYSICIAN TIGHTENED THE SCREW UNTIL IT CLICKED AND THEN UNSCREWED THE SCREW BUT WAS STILL NOT ABLE TO REMOVE THE LEAD. THE SURGEON COMPLETED THE REPOSITIONING OF THE GENERATOR WHICH WAS PERFORMED FOR PATIENT COMFORT AND LEFT THE LEAD IMPLANTED. THE DEVICE DIAGNOSTICS WERE WITHIN NORMAL LIMIT. MANUFACTURER REVIEWED THE DESIGN HISTORY DOCUMENT OF GENERATOR AND NO ANOMALIES WERE OBSERVED WITH THE DEVICE.

    Description of Event or Problem · 1

    ON (B)(4) 2011, REVIEW OF MANUFACTURING RECORDS CONFIRMED THAT THE DEVICE MET SPECIFICATIONS AND NO ANOMALIES WERE OBSERVED PRIOR TO THE DEVICE LEAVING THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 200746

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR