BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 3822071 · Received May 20, 2014

    Report

    Report Number
    1644487-2014-01337
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    April 25, 2014
    Report Date
    April 25, 2014
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INITIAL VNS SYSTEM IMPLANT THE PATIENT EXPERIENCED BRADYCARDIA DURING A SYSTEM DIAGNOSTICS TEST. IT WAS REPORTED THAT THE PATIENT MADE A FULL RECOVERY AND THE IMPLANT WAS COMPLETED. IT WAS REPORTED THAT THE PATIENT DID NOT EXPERIENCE ANY POST-OPERATIVE ISSUES AND THE BRADYCARDIA WAS ISOLATED TO THE SYSTEM DIAGNOSTICS TEST. ATTEMPTS TO OBTAIN ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299477 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS INC 103 202551

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other