BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 304

    MDR report key: 3051476 · Received April 10, 2013

    Report

    Report Number
    1644487-2013-00983
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 14, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF MANUFACTURING HISTORY RECORDS PERFORMED. REVIEW OF MANUFACTURING HISTORY RECORDS CONFIRMED THAT ALL QUALITY STEPS 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

    AP AND LATERAL X-RAYS OF THE NECK AND CHEST TAKEN DATED (B)(6) 2013 WERE RECEIVED BY THE MANUFACTURER FOR REVIEW ON (B)(6) 2013. IT IS UNABLE TO BE CONFIRMED IF THE LEAD PIN IS FULLY INSERTED INTO THE GENERATOR CONNECTOR BLOCK DUE TO THE PIXELATED IMAGE QUALITY. BASED ON THE X-RAY RECEIVED THERE WAS NOTHING SEEN THAT WOULD INDICATE THERE WAS ANY DAMAGE TO THE GENERATOR OR LEAD; HOWEVER, THE PRESENCE OF A MICRO-FRACTURE IN THE LEAD CANNOT BE RULED OUT. DUE TO IMAGES NOT BEING PROVIDED ON CD AND THE SIZE AND IMAGE QUALITY OF THE IMAGES PROVIDED A FULL ASSESSMENT OF THE IMPLANTED PRODUCTS COULD NOT BE PERFORMED. CLINIC NOTES DATED (B)(6) 2013 FROM THE NEUROLOGIST REPORTED THAT THE PATIENT¿S ASSISTANCE WITH SEIZURE CONTROL HAS BEEN IRREGULAR SINCE IMPLANT WITH VNS IN (B)(6) 2011. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    THE PATIENT IS BEING REFERRED TO NEUROSURGERY. HOWEVER, THE SURGERY HAS NOT OCCURRED TO DATE. THE PHYSICIAN REPORTED THAT HE CANNOT EVALUATE THE PATIENT¿S BENEFIT WITH VNS THERAPY BECAUSE THE PATIENT WAS LOST FOR FOLLOW UP FOR A LONG TIME. RIGHT NOW, THE PATIENT IS STABLE BECAUSE THE PHYSICIAN ADJUSTED THE MEDICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HIGH IMPEDANCE WAS OBSERVED ON BOTH SYSTEM AND NORMAL DIAGNOSTICS ON (B)(6) 2013 WITH LEAD IMPEDANCE GREATER THAN 10,000 OHMS. THE PATIENT'S DEVICE WAS THEN TURNED OFF ON THIS DATE, AND THE PATIENT WAS REFERRED FOR X-RAYS. NO PATIENT MANIPULATION OR TRAUMA OCCURRED THAT IS BELIEVED TO HAVE CAUSED OR CONTRIBUTED TO THE HIGH IMPEDANCE. ATTEMPTS FOR X-RAY RETURN ARE UNDERWAY, BUT THEY HAVE NOT BEEN REVIEWED BY THE MANUFACTURER TO DATE. ALTHOUGH SURGERY IS LIKELY, THE SURGERY HAS NOT OCCURRED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148499 LEAD MODEL 304 LEAD LYJ CYBERONICS, INC. 304-20 201709

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR