BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL UNKNOWN

    MDR report key: 2240990 · Received August 17, 2011

    Report

    Report Number
    1644487-2011-01893
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 18, 2011
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 BY A NURSE THROUGH A COMPANY REPRESENTATIVE THAT HIGH LEAD IMPEDANCE (>10,000 OHMS) WAS ENCOUNTERED AT A FOLLOW-UP APPOINTMENT. THE PT'S GENERATOR WAS PROGRAMMED OFF DUE TO HIGH LEAD IMPEDANCE AND WAS REFERRED FOR X-RAYS. MOREOVER, THE PT'S MOTHER INDICATED THAT SHE NOTED A WORSENING IN SEIZURES BEING THAT THE CHILD DOES NOT SPEAK. FURTHER INFORMATION WERE RECEIVED BY A COMPANY REPRESENTATIVE INDICATING THAT THE HIGH IMPEDANCE WAS NOTED TO HAVE FLUCTUATED FORM HIGH TO NORMAL VALUE SINCE (B)(6) 2010. MOREOVER, THE PT'S REPORTED WORSENING IN SEIZURES REMAINS LESS THAN PRE-VNS BASELINE. X-RAYS WERE RECEIVED BY THE MANUFACTURER AND REMAIN UNDER REVIEW. FURTHERMORE, AT THE MOMENT LEAD REVISION HAS BEEN PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL UNKNOWN LYJ CYBERONICS INC

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR