BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3001730 · Received March 13, 2013

    Report

    Report Number
    1644487-2013-00687
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 11, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT FELT THAT HIS HEART RATE WAS VERY SLOW. IT IS UNKNOWN IF THE SLOWED HEART RATED WAS RELATED TO VNS. GOOD FAITH ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104669 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS INC 102 8125

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR