BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 304

    MDR report key: 3123922 · Received May 22, 2013

    Report

    Report Number
    1644487-2013-01544
    Event Type
    Injury
    Date Received
    May 22, 2013
    Date of Event
    April 23, 2013
    Report Date
    February 5, 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
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS VNS PATIENT UNDERWENT LEAD REPOSITIONING SURGERY FOR AN UNKNOWN REASON ON (B)(6) 2013. IT WAS INITIALLY STATED THAT LEAD WAS GOING TO BE REPLACED FOR AN UNKNOWN REASON; HOWEVER, IT WAS LATER REPORTED THAT NO DEVICES WERE EXPLANTED OR IMPLANTED. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225859 LEAD MODEL 304 LEAD LYJ LIVANOVA USA, INC. 304-20 2831

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other