BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1022713 · Received March 26, 2008

    Report

    Report Number
    1644487-2008-00789
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    February 26, 2008
    Report Date
    February 28, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MALFUNCTION SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE VNS PATIENT UNDERWENT GENERATOR REPLACEMENT SURGERY ON (B)(6) 2008. IT IS UNKNOWN IF THE LEAD WAS REVISED AT THE TIME.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT BOTH THE GENERATOR AND LEAD WERE REPLACED ON (B)(6) 2008.

    Description of Event or Problem · 1

    INITIAL REPORTER INDICATED THE PT HAD HIGH LEAD IMPEDANCE INDICATING A POSSIBLE LEAD MALFUNCTION. GOOD FAITH ATTEMPTS HAVE BEEN MADE FOR ADD'L INFO SURROUNDING THE EVENT WHICH HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 8350

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR