BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASPIRE SR MODEL 106 GENERATOR

    MDR report key: 17875968 · Received October 4, 2023

    Report

    Report Number
    MW5146569
    Event Type
    Injury
    Date Received
    October 4, 2023
    Report Date
    October 3, 2023
    Manufacturer
    CYBERONICS, INC. / LIVANOVA USA, INC
    Product Code
    MUZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PROCEDURE WAS REMOVAL AND REPLACEMENT OF VAGAL NERVE STIMULATOR ON (B)(6) 2022. THE PATIENT¿S SURGICAL HISTORY CONSISTED OF A SURGERY WAS DONE IN GERMANY, TO HAVE SHRAPNEL TAKEN OUT, DUE TO BEING HIT BY IED IN IRAQ, IT WAS REPORTED THAT SINCE THEN SEIZURES STARTED. PRE AND POST-OP DIAGNOSIS WAS SEIZURE DISORDER, INTRACTABLE (HC CODE). THE EXPLANTED VAGAL NERVE STIMULATOR WAS SENT IN WITH NO DEVICE/THERAPY ALLEGATION REPORT WITH THE RETURNED PRODUCT. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225321 ASPIRE SR MODEL 106 GENERATOR STIMULATOR, AUTONOMIC NERVE, IMPLANTED (DEPRESSION) MUZ CYBERONICS, INC. / LIVANOVA USA, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown