BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 4061665 · Received September 4, 2014

    Report

    Report Number
    1644487-2014-02233
    Event Type
    Malfunction
    Date Received
    September 4, 2014
    Date of Event
    October 17, 2013
    Report Date
    August 8, 2014
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY. DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    DURING REVIEW OF THE IN-HOUSE PROGRAMMING/DIAGNOSTIC HISTORY DATABASE, IT WAS OBSERVED THAT HIGH LEAD IMPEDANCE WAS DETECTED ON (B)(6) 2013. THE PATIENT HAD GENERATOR AND LEAD REPLACEMENT SURGERY ON (B)(6) 2014. IT WAS REPORTED THAT EXPLANTED PRODUCTS ARE USUALLY DISCARDED BY THE HOSPITAL IN THE OPERATING ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541965 LEAD MODEL 302 LEAD LYJ CYBERONICS INC 302-20 1514

    Patients

    Seq Age Sex Outcome Treatment
    1