BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 4100269 · Received September 18, 2014

    Report

    Report Number
    1644487-2014-02377
    Event Type
    Injury
    Date Received
    September 18, 2014
    Date of Event
    August 20, 2014
    Report Date
    August 20, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT¿S DEVICE SHOWED AN IFI CONDITION DURING AN OFFICE VISIT ON (B)(6) 2014. THE PATIENT WAS REFERRED FOR SURGICAL CONSULT. ON (B)(6) 2014, THE PATIENT REPORTED HAVING AN INCREASE IN SEIZURES, SO THE SURGICAL CONSULT DATE WAS MOVED TO AN EARLIER DATE. THE PATIENT UNDERWENT GENERATOR REPLACEMENT SURGERY ON (B)(6) 2014. THE EXPLANTED GENERATOR HAS NOT BEEN RETURNED TO DATE. ATTEMPTS FOR ADDITIONAL RELEVANT INFORMATION WILL BE MADE.

    Description of Event or Problem · 1

    AN IMPLANT CARD WAS RECEIVED INDICATING THAT THE PATIENT UNDERWENT GENERATOR REPLACEMENT DUE TO BATTERY DEPLETION, UNABLE TO INTERROGATE DUE TO BATTERY DEPLETION. IT WAS REPORTED THAT THE SURGEON DISCARDS EXPLANTED DEVICES IN THE SURGERY; THEREFORE ANALYSIS CANNOT BE PERFORMED. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580252 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 200929

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention