BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 3688980 · Received March 19, 2014

    Report

    Report Number
    1644487-2014-00727
    Event Type
    Malfunction
    Date Received
    March 19, 2014
    Date of Event
    January 29, 2014
    Report Date
    February 18, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS OF THE LEAD 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

    AN IMPLANT CARD WAS RECEIVED INDICATING THAT THE PATIENT UNDERWENT GENERATOR AND LEAD REPLACEMENT DUE TO LEAD DISCONTINUITY. ATTEMPTS TO OBTAIN ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED THAT HIGH IMPEDANCE WAS OBSERVED IN 2013 (EXACT DATE UNKNOWN). THE PHYSICIAN REPORTED THAT IT IS UNKNOWN IF ANY PATIENT MANIPULATION OR TRAUMA OCCURRED THAT IS BELIEVED TO HAVE CAUSED OR CONTRIBUTED TO THE HIGH IMPEDANCE. IT WAS REPORTED THAT THE EXPLANTED DEVICES ARE NOT AVAILABLE TO BE RETURNED FOR ANALYSIS TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162317 LEAD MODEL 302 LEAD MUZ CYBERONICS, INC. 302-20 1898

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR