BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 3022540 · Received March 27, 2013

    Report

    Report Number
    1644487-2013-00825
    Event Type
    Injury
    Date Received
    March 27, 2013
    Report Date
    March 8, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CLINIC NOTES DATED (B)(6) 2012 WERE RECEIVED ON (B)(6) 2013 AND INDICATED THAT THIS VNS PATIENT HAD A HISTORY OF SYNCOPE. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(4) 2013 THAT THE SYNCOPE WAS NOT RELATED TO VNS. PRODUCT INFORMATION WAS ALSO OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124996 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 201958

    Patients

    Seq Age Sex Outcome Treatment
    1