BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 1081940 · Received July 23, 2008

    Report

    Report Number
    1644487-2008-01684
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    June 1, 2008
    Report Date
    June 24, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF X-RAYS BY THE MANUFACTURER REVEALED A GROSS LEAD DISCONTINUITY. DEVICE FAILURE OCCURRED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    REPORTER INDICATED THAT SYSTEM AND NORMAL MODE DIAGNOSTIC TESTS SHOWED HIGH LEAD IMPEDANCE. IT WAS REPORTED THAT THE PATIENT HAD AN "INTENSE EPISODE" OF CHEST PAIN THE PREVIOUS WEEKEND AND THE MAGNET WAS USED TO DISABLE THE DEVICE, AN ICE PACK WAS PLACED ON THE PATIENT'S CHEST, AND HE WAS GIVEN A "MILD ANGELGESIC" DUE TO THE PAIN. THE PATIENT'S CAREGIVER REPORTED THAT THERE WAS NO TRAUMA, PATIENT MANIPULATION OR OTHER INTERACTIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. X-RAYS WERE REVIEWED BY THE MANUFACTURER AND IT WAS IDENTIFIED THAT THE NEGATIVE FILTER FEEDTHROUGH WAS NOT INTACT. REVISION SURGERY IS LIKELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOL LEAD MODEL 300 LYJ CYBERONICS, INC. 300-20 40535C

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR