BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2833992 · Received November 15, 2012

    Report

    Report Number
    1644487-2012-03024
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    October 22, 2012
    Report Date
    October 22, 2012
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE X-RAYS REVIEWED BY THE MANUFACTURER, NO GROSS LEAD DISCONTINUITIES VISUALIZED. DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    REPORTER INDICATED A VNS PATIENT HAD LOW LEAD IMPEDANCE 60:000 OHMS WITH DEVICE DIAGNOSTICS. THE PATIENT IS HAVING NO ADVERSE EVENTS AT THIS TIME, AND IS SEIZURE-FREE. THE PATIENT HAD NO TRAUMA AND DOES NOT MANIPULATE THE VNS. THE REPORTER DECLINED TO DISABLE THE VNS, AS THE PATIENT IS DOING WELL CLINICALLY WITH HER SEIZURES. THE REPORTER WAS MADE AWARE OF THE MANUFACTURER'S RECOMMENDATION TO DISABLE THE VNS DUE TO THE LOW IMPEDANCE. X-RAYS WERE REVIEWED BY THE MANUFACTURER AND NO OBVIOUS LEAD ANOMALIES WERE NOTED. THERE WAS A SLIGHT TWIST TO THE LEAD BODY IN APPROXIMATELY THE FIRST 1/3 OF THE AVAILABLE LEAD BODY VIEW, BUT THIS MAY NOT BE A SIGNIFICANT FINDING. THE LEAD PIN WAS FULLY INSERTED. THE FILTER FEEDTHRUS WERE INTACT. THERE WAS SOME LEAD BEHIND THE GENERATOR THAT CANNOT BE ASSESSED. THE LEAD WAS INTACT AT THE LEAD PIN. THE CAUSE OF THE LOW LEAD IMPEDANCE IS NOT APPARENT IN THE X-RAYS, BUT MAY BE DUE TO A POSSIBLE SHORT IN THE LEAD BODY UNDER THE GENERATOR OR IN A DIFFERENT AREA OF THE LEAD. THE PLAN OF CARE IS TO CONTINUE TO OBSERVE THE PATIENT CLINICALLY WITH THE VNS ENABLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LEAD LYJ CYBERONICS INC 302-20 8434

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR