BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 304

    MDR report key: 4180541 · Received October 17, 2014

    Report

    Report Number
    1644487-2014-02734
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    July 7, 2014
    Report Date
    September 18, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 REFERRED FOR REPLACEMENT SURGERY DUE TO UNKNOWN REASONS. AN IMPLANT CARD WAS RECEIVED INDICATING THAT THE PATIENT UNDERWENT GENERATOR REPLACEMENT SURGERY ON (B)(6) 2014. FOLLOW-UP REVEALED THAT THE PATIENT¿S DEVICE SHOWED HIGH IMPEDANCE DURING AN OFFICE VISIT ON (B)(6) 2014. CLINIC NOTES STATED THAT THE PATIENT¿S ¿VNS [WAS] NOT FUNCTIONING¿. IT IS UNKNOWN IF THE PATIENT¿S LEAD WAS ALSO REPLACED DURING THE PROCEDURE. ATTEMPTS FOR ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT ONLY THE VNS PATIENT¿S GENERATOR WAS REPLACED. THE EXPLANTING FACILITY DISCARDED THE EXPLANTED DEVICE; THEREFORE, NO ANALYSIS CAN BE PERFORMED. THE PATIENT¿S DEVICE HAD SHOWN HIGH IMPEDANCE AND NEAR END OF LIFE. THE PHYSICIAN ATTRIBUTED THE HIGH IMPEDANCE TO THE LOW BATTERY CONDITION OF THE GENERATOR. THE PATIENT WAS DOING WELL FOLLOWING GENERATOR REPLACEMENT SURGERY. A BATTERY LIFE CALCULATION USING THE AVAILABLE PROGRAMMING HISTORY SHOWED APPROXIMATELY 0.1 YEARS UNTIL NEOS = YES. ATTEMPTS FOR ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE VNS PATIENT WAS SEEN ON (B)(6) 2014 FOLLOWING GENERATOR REPLACEMENT SURGERY AND THAT THE PATIENT¿S DEVICE WAS FUNCTIONING WELL AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663274 LEAD MODEL 304 LEAD LYJ CYBERONICS, INC. 304-20 201584

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR