BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 3060373 · Received April 16, 2013

    Report

    Report Number
    1644487-2013-01028
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    February 5, 2013
    Report Date
    March 22, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    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

    ON (B)(4) 2013, IT WAS REPORTED THAT THE VNS PATIENT HAS HIGH IMPEDANCE THAT WAS FIRST OBSERVED ON (B)(6) 2013. DIAGNOSTICS SHOWED OUTPUT=LIMIT/LEAD IMPEDANCE=HIGH/DCDC=7/EOS=NO. IT WAS REPORTED THAT THE GENERATOR HAD BEEN DISABLED DUE TO THE HIGH IMPEDANCE. THE PHYSICIAN STATED THAT NO SPECIFIC TRAUMA HAS OCCURRED BUT THE PATIENT HAS MANY BIG SEIZURES. THE SEIZURE FREQUENCY IS UNCHANGED. THE PATIENT WAS REFERRED FOR SURGERY. ALTHOUGH SURGERY IS LIKELY, IT HAS NOT OCCURRED TO DATE. A COPY OF THE PATIENT'S X-RAYS WERE RECEIVED ON (B)(6) 2013. THE LEAD CONNECTOR PINS SEEM TO BE FULLY INSERTED INTO THE GENERATOR CONNECTOR BLOCK. PART OF LEAD IS PLACED BEHIND THE GENERATOR AND COULD NOT BE ASSESSED. NO OBVIOUS LEAD FRACTURE OR SHARP ANGLE WAS IDENTIFIED. BASED ON THE X-RAYS IMAGE, NO CONCLUSION CAN BE DRAWN ON CAUSE OF THE REPORTED HIGH IMPEDANCE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON APRIL 17, 2013 WHEN A BATTERY LIFE CALCULATION WAS PERFORMED ON THE PATIENT¿S GENERATOR THAT SHOWED 5.04 YEARS REMAINING UNTIL ERI=YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163688 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 11652

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR