BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 4192693 · Received October 22, 2014

    Report

    Report Number
    1644487-2014-02777
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    October 15, 2014
    Report Date
    October 15, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING HISTORY RECORDS WERE REVIEWED. REVIEW OF THE LEAD DEVICE HISTORY RECORDS CONFIRMED ALL QUALITY TESTS WERE PASSED PRIOR TO DISTRIBUTION. 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 THAT SYSTEM AND NORMAL MODE DIAGNOSTICS RESULTED IN HIGH LEAD IMPEDANCE. X-RAYS WERE REPORTEDLY PERFORMED, BUT THE NURSE DID NOT OBSERVE ANY LEAD DISCONTINUITIES. SURGICAL INTERVENTION HAS NOT OCCURRED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD GENERATOR AND LEAD REPLACEMENT SURGERY ON (B)(6) 2014. THE EXPLANTED DEVICES WERE DISCARDED BY THE OR STAFF AND WILL NOT BE RETURNED TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671093 BIPOL LEAD MODEL 300 LEAD LYJ CYBERONICS, INC. 300-20 27733C

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR