BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 3243485 · Received July 23, 2013

    Report

    Report Number
    1644487-2013-02218
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    January 1, 2013
    Report Date
    June 25, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE IS SUSPECTED BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    CLINIC NOTES DATED (B)(6) 2103 INDICATED THAT THIS VNS INTERROGATION SHOWED HIGH IMPEDANCE. A CHEST X-RAY WAS OBTAINED, BUT THERE WAS NO EVIDENCE OF A DISCONTINUITY. NOTES INDICATED THAT THE VNS APPEAR TO REDUCE SEIZURE FREQUENCY BY HALF BUT DID NOT AFFECT DURATION OR SEVERITY. IN (B)(6) 2013, THE SEIZURES STARTED INCREASE BACK TO PREVIOUS BASELINE, AND SEIZURES ARE NOT STOPPING WITH MAGNET SWIPES LIKE THEY USED TO. THERE WAS REPORTEDLY HIGH IMPEDANCE IN (B)(6) 2013 WHEN THE PATIENT¿S DEVICE WAS INTERROGATED. SURGERY IS LIKELY BUT HAS NOT TAKEN PLACE.

    Description of Event or Problem · 1

    AN IMPLANT CARD RECEIVED ON (B)(6) 2013 INDICATED THAT THIS VNS PATIENT UNDERWENT FULL REVISION ON (B)(6) 2013. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN PER HOSPITAL POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343444 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 2205

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR