BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 3771206 · Received April 24, 2014

    Report

    Report Number
    1644487-2014-01107
    Event Type
    Injury
    Date Received
    April 24, 2014
    Date of Event
    March 27, 2014
    Report Date
    September 24, 2021
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED IN STATUS EPILEPTICUS. IT WAS REPORTED THAT THE PATIENT'S PHYSICIAN WOULD SEE THE PATIENT FOR FOLLOW-UP WITH VNS THERAPY. ATTEMPTS TO OBTAIN ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE VNS PATIENT¿S DEVICE COULD NOT BE INTERROGATED. THREE DIFFERENT PROGRAMMING SYSTEMS WERE USED BUT ALL WERE UNSUCCESSFUL. THE FAILURE TO INTERROGATE IS BELIEVED TO BE DUE TO END OF SERVICE AS THE PATIENT¿S DEVICE REPORTEDLY SHOWED AN END OF SERVICE CONDITION SIX MONTHS AGO. NO KNOWN SURGICAL INTERVENTIONS HAVE OCCURRED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249697 PULSE GEN MODEL 102R GENERATOR LYJ LIVANOVA USA, INC. 102R 010657

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization