BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 3934426 · Received July 15, 2014

    Report

    Report Number
    1644487-2014-01774
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    April 21, 2014
    Report Date
    June 17, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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

    IT WAS REPORTED THAT DEVICE DIAGNOSTICS RESULTED IN HIGH IMPEDANCE. NO PATIENT MANIPULATION OR TRAUMA OCCURRED THAT IS BELIEVED TO HAVE CAUSED OR CONTRIBUTED TO THE HIGH IMPEDANCE. IT IS UNKNOWN IF THE GENERATOR WAS PROGRAMMED OFF AFTER OBSERVING THE HIGH IMPEDANCE. X-RAYS WERE PERFORMED AND SENT TO MANUFACTURER FOR REVIEW. THE LEAD PIN APPEARED TO BE FULLY INSERTED INTO THE GENERATOR HEADER. A LEAD FRACTURE WAS OBSERVED CLOSE TO THE RIGHT TIE-DOWN WHERE BOTH WIRES APPEARED BROKEN. BASED ON THE IMAGES RECEIVED THE CAUSE OF THE HIGH IMPEDANCE APPEARS TO BE A LEAD FRACTURE. ATTEMPTS TO OBTAIN ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE. NO SURGICAL INTERVENTION HAS BEEN PERFORMED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CANCELLED THE SURGERY AND IS NO LONGER WILLING TO DO THE PROCEDURE. IT WAS REPORTED THAT THE PHYSICIAN LOST CONTACT WITH THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS NOT PROGRAMMED OFF AFTER OBSERVING THE HIGH IMPEDANCE. SURGERY IS PLANNED, BUT HAS NOT OCCURRED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412182 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 3167

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR