BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 4102892 · Received September 19, 2014

    Report

    Report Number
    1644487-2014-02404
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    July 14, 2014
    Report Date
    August 22, 2014
    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
    HEALTH PROFESSIONAL

    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

    IT WAS REPORTED THAT DURING GENERATOR REPLACEMENT SURGERY ON (B)(6) 2014 DUE TO END OF SERVICE, THE VNS PATIENT¿S REPLACEMENT GENERATOR AND EXISTING LEAD WERE TESTED AND HIGH IMPEDANCE WAS OBSERVED. THE LEAD WAS NOT REPLACED DURING THE PROCEDURE DUE TO TIME CONSTRAINTS. THE PATIENT UNDERWENT LEAD REPLACEMENT SURGERY ON (B)(6) 2014. THE EXPLANTED GENERATOR AND LEAD HAVE NOT BEEN RETURNED TO DATE.

    Description of Event or Problem · 1

    THE EXPLANTING FACILITY WILL NOT RETURN EXPLANTED DEVICES TO THE MANUFACTURER FOR ANALYSIS; THEREFORE, NO ANALYSIS CAN BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HIGH IMPEDANCE WAS NOT OBSERVED PRIOR TO GENERATOR REPLACEMENT SURGERY. IT WAS REPORTED THAT NO PRE-OPERATIVE DIAGNOSTICS WERE PERFORMED PRIOR TO THE GENERATOR REPLACEMENT. CLINIC NOTES DATED (B)(6) 2014 NOTE THAT THE EPILEPTOLOGIST IDENTIFIED HIGH IMPEDANCE AND VNS LEAD MALFUNCTION WAS SUSPECTED. THE DEVICE WAS NOT PROGRAMMED OFF AFTER OBSERVING THE HIGH IMPEDANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584562 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 200593

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR