BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 3963735 · Received July 29, 2014

    Report

    Report Number
    1644487-2014-01884
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    June 27, 2014
    Report Date
    July 3, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RECENTLY IMPLANTED VNS PATIENT¿S DEVICE WAS INTERROGATED DURING AN OFFICE VISIT ON (B)(6) 2014. THE DEVICE SHOWED A MESSAGE STATING ¿VBATT < EOS THRESHOLD.¿ THE NEUROSURGEON STATED THAT ELECTROCAUTERY WAS NOT USED DURING THE IMPLANT PROCEDURE. THE PATIENT UNDERWENT GENERATOR REPLACEMENT SURGERY ON (B)(6) 2014. THE EXPLANTED GENERATOR WAS RETURNED TO THE MANUFACTURER WHERE ANALYSIS IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    ANALYSIS OF THE RETURNED GENERATOR WAS COMPLETED. BURN MARKS WERE OBSERVED ON THE PULSE GENERATOR CASE, INDICATING THAT THE PULSE GENERATOR MAY HAVE BEEN EXPOSED TO AN ELECTRO-CAUTERY TOOL DURING DEVICE IMPLANT, WHICH MAY HAVE BEEN A CONTRIBUTING FACTOR. A RESET OF THE PULSEDISABLE BIT IN THE GENERATOR MEMORY WAS PERFORMED TO ALLOW FOR AN OUTPUT TO ONCE AGAIN BE PROVIDED BY THE GENERATOR FOR SUBSEQUENT TESTING. THE DEVICE SHOWED A NON-IFI CONDITION. OTHER THAN THE NOTED EVENT, THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITION FOUND WITH THE PULSE GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440975 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 3832

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR