BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1800079 · Received August 11, 2010

    Report

    Report Number
    1644487-2010-01837
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Date of Event
    July 15, 2010
    Report Date
    July 15, 2010
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    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

    REPORTER INDICATED A VNS PT HAD HIGH LEAD IMPEDANCE WITH VNS DIAGNOSTICS TESTING; IT IS UNK IF THE HIGH LEAD IMPEDANCE WAS OBTAINED WITH SYSTEMS OR NORMAL MODE DIAGNOSTICS. NO PT ADVERSE EVENTS WERE REPORTED. THE PT LATER HAD VNS LEAD REPLACEMENT DUE TO THE HIGH LEAD IMPEDANCE. THE EXPLANTED LEAD HAS BEEN RETURNED AND IS CURRENTLY IN PRODUCT ANALYSIS. PAPERWORK RECEIVED WITH THE LEAD INDICATED THE LEAD WAS REPLACED DUE TO "SUSPECTED LEAD BREAKAGE". ATTEMPTS FOR FURTHER INFO ARE IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS INC 302-20 200411

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR