BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 2141183 · Received June 22, 2011

    Report

    Report Number
    1644487-2011-01410
    Event Type
    Injury
    Date Received
    June 22, 2011
    Date of Event
    May 27, 2011
    Report Date
    May 27, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PT WAS EXPERIENCING AN INCREASE IN SEIZURES AND THAT HER GENERATOR WAS BELIEVED TO BE DEAD. ADD'L INFO WAS RECEIVED INDICATING THAT THE PT UNDERWENT A GENERATOR REPLACEMENT PROCEDURE ON (B)(6) 2011. ATTEMPTS FOR ADD'L INFO AND PRODUCT RETURN HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102R LYJ CYBERONICS, INC. 102R 200776

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention