BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1102492 · Received August 8, 2008

    Report

    Report Number
    1644487-2008-01604
    Event Type
    Malfunction
    Date Received
    August 8, 2008
    Date of Event
    July 6, 2008
    Report Date
    May 20, 2022
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VNS PATIENT WAS EXPERIENCING PAIN AND TWITCHING IN THE UPPER LEFT CHEST NOT DURING STIMULATION. DIAGNOSTIC TESTS WERE PERFORMED AND THE RESULTS WERE WITHIN ACCEPTABLE LIMITS. THE PATIENT CONTINUED TO FEEL THIS PAIN EVEN AFTER THE DEVICE WAS PROGRAMMED OFF AND GENERATOR REVISION SURGERY WAS PERFORMED. THE EXPLANTED GENERATOR WAS RETURNED TO THE MANUFACTURER AND IS CURRENTLY AWAITING ANALYSIS. AN ASSOCIATE OF THE REPORTER DIAGNOSED THE EVENT AS A POSSIBLE PERIPHERAL NERVE EVENT. IN RESPONSE TO THE CONTINUED PAIN EVENT, THE PATIENT WILL UNDERGO LEAD REVISION SURGERY WITHIN THE MONTH; A SURGERY DATE HAS NOT BEEN FINALIZED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female Required Intervention