BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL UNKNOWN

    MDR report key: 4213538 · Received October 30, 2014

    Report

    Report Number
    1644487-2014-02892
    Event Type
    Malfunction
    Date Received
    October 30, 2014
    Date of Event
    October 3, 2014
    Report Date
    October 3, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    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 THE VNS PATIENT WAS SCHEDULED TO UNDERGO SURGERY DUE TO A LEAD FRACTURE. THE PATIENT HAD BEEN EXPERIENCING AN INCREASE IN SEIZURES. IT WAS NOTED THAT VNS PATIENT WENT FROM 40 SEIZURES PER MONTH TO TWO SEIZURES PER MONTH WITH VNS. THE PATIENT UNDERWENT SURGERY ON (B)(6) 2014, BUT ONLY THE PATIENT¿S GENERATOR WAS REPLACED DURING THE PROCEDURE DUE TO END OF SERVICE. IT IS UNCLEAR IF GENERATOR REPLACEMENT RESOLVED THE LEAD ISSUE. ATTEMPTS FOR ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE. THE EXPLANTED GENERATOR HAS BEEN RETURNED TO THE MANUFACTURER WHERE ANALYSIS IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    ANALYSIS OF THE RETURNED GENERATOR WAS COMPLETED. THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR. MONITORING OF THE DEVICE OUTPUT SIGNAL SHOWED NO SIGNS OF VARIATION IN THE PULSE GENERATOR¿S OUTPUT SIGNAL AND DEMONSTRATED THAT THE DEVICE PROVIDED THE EXPECTED LEVEL OF OUTPUT CURRENT. THE PULSE GENERATOR DIAGNOSTICS WERE AS EXPECTED FOR THE PROGRAMMED PARAMETERS. IN ADDITION, A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THE AS-RECEIVED INTERNAL DEVICE DATA SHOWED THAT THE LAST 25% CHANGE IN THE IMPEDANCE VALUE OCCURRED AT REPLACEMENT SURGERY ON (B)(6) 2014. PRIOR TO THIS CHANGE, THE PATIENT¿S DEVICE SHOWED HIGH IMPEDANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695579 LEAD MODEL UNKNOWN LEAD LYJ CYBERONICS, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention