BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 3923830 · Received July 9, 2014

    Report

    Report Number
    1644487-2014-01744
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 12, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT, CORRECTED DATA: THE INITIAL REPORT INADVERTENTLY REPORTED THIS INCORRECTLY.

    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

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAD A LEAD AND GENERATOR REPLACEMENT. A LEAD FRACTURE WAS REPORTED TO HAVE BEEN SEEN BY THE SURGEON NEAR THE BIFURCATION OF THE LEAD. ATTEMPTS FOR PRODUCT RETURN HAVE BEEN UNSUCCESSFUL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DEVICE DIAGNOSTICS RESULTED IN HIGH IMPEDANCE (10,000 OHMS). THE PHYSICIAN REPORTED THAT THE HIGH IMPEDANCE IS MOST LIKELY DUE TO THE PATIENT MANIPULATING (TWIDDLING) THE LEAD THROUGH THE SKIN; HOWEVER, HE WAS NOT CERTAIN. THE DEVICE WAS NOT PROGRAMMED OFF. IT WAS REPORTED THAT THE PHYSICIAN IS INTERESTED IN SEEING HOW LONG THE PATIENT WILL HAVE GREAT SEIZURE CONTROL AND X-RAYS MAY BE PERFORMED IN THE FUTURE. NO SURGICAL INTERVENTION HAS BEEN PERFORMED TO DATE.

    Description of Event or Problem · 1

    THE EXPLANTED PRODUCTS HAVE NOT BEEN RECEIVED BY THE MANUFACTURER TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAD THE GENERATOR IS REPORTED AS HAVING BEEN TURNED OFF AND X-RAYS OF NECK AND CHEST WERE TAKEN. CLINIC NOTE INDICATED THAT THE GENERATOR WAS TURNED BACK ON AFTER THE X-RAYS. THE PATIENT HAS BEEN HAVING RECENT SEIZURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401077 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 011314

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Other