BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 304

    MDR report key: 3770336 · Received April 24, 2014

    Report

    Report Number
    1644487-2014-01099
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 1, 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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING RECORDS AND AVAILABLE PROGRAMMING AND DIAGNOSTIC HISTORY WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED THAT THE LEAD PASSED ALL FUNCTIONAL TESTS 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 HAS BEEN HAVING 4-5 DROP ATTACKS PER DAY. ALTHOUGH SURGERY IS LIKELY, IT HAS NOT OCCURRED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT FULL REVISION SURGERY. THE EXPLANTED LEAD AND GENERATOR HAVE NOT BEEN RECEIVED TO DATE. DEVICE DIAGNOSTICS WITH THE NEW LEAD AND GENERATOR WERE WITHIN NORMAL LIMITS.

    Description of Event or Problem · 1

    ON (B)(4) 2014, IT WAS REPORTED THAT THE PATIENT HAD BEEN HAVING QUITE A FEW SEIZURES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HIGH LEAD IMPEDANCE WAS OBSERVED FOR THE VNS PATIENT¿S DEVICE. THE PATIENT WAS SUBSEQUENTLY PROGRAMMED OFF. PATIENT MANIPULATION OR TRAUMA IS NOT BELIEVED TO HAVE CAUSED OR CONTRIBUTED TO THE HIGH IMPEDANCE. THE PATIENT WAS REPORTED TO BE DOING WELL. REVIEW OF THE AVAILABLE PROGRAMMING AND DIAGNOSTIC HISTORY SHOWED THE LAST NORMAL DIAGNOSTIC RESULTS WERE FROM (B)(6) 2011. NO KNOWN INTERVENTIONS HAVE OCCURRED TO DATE. ATTEMPTS FOR ADDITIONAL RELEVANT INFORMATION WERE MADE BUT HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXPLANTED LEAD AND GENERATOR WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249007 LEAD MODEL 304 LEAD LYJ CYBERONICS, INC. 304-20 201584

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR