BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2092156 · Received April 27, 2011

    Report

    Report Number
    1644487-2011-00902
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 28, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR REVIEWED X-RAYS OF IMPLANTED DEVICE. X-RAYS REVIEWED BY THE MFR, NO GROSS LEAD DISCONTINUITIES VISUALIZED. DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT PRESENTED HIGH LEAD IMPEDANCE (SPECIFIC RESULTS NOT PROVIDED) AT A ROUTINE OFFICE VISIT. THE PT'S DEVICE WAS PROGRAMMED OFF AND THE PT WAS REFERRED FOR REVISION SURGERY WHICH HAS NOT TAKEN PLACE TO DATE. ADDITIONAL INFO RECEIVED FROM THE SITE REVEALED THAT THERE WERE NO REPORTS OF ANY MANIPULATION OR TRAUMA THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE HIGH LEAD IMPEDANCE. X-RAYS WERE TAKEN AND SENT TO THE MFR FOR REVIEW. THERE WERE NO OBVIOUS ANOMALIES FOR CAUSES FOR THE HIGH LEAD IMPEDANCE IDENTIFIED HOWEVER DUE TO THE QUALITY OF THE IMAGES, COMPLETED LEAD PIN INSERTION COULD NOT BE ASSESSED. ADDITIONALLY, A PORTION OF THE LEAD WAS BEHIND THE GENERATOR AND CONTINUITY OF THE LEAD BODY IN THAT PORTION OF THE LEAD COULD NOT BE ASSESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 7150

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR