BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 4802826 · Received May 28, 2015

    Report

    Report Number
    1644487-2015-04798
    Event Type
    Injury
    Date Received
    May 28, 2015
    Date of Event
    May 4, 2015
    Report Date
    May 4, 2015
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE AVAILABLE PROGRAMMING AND DIAGNOSTIC HISTORY.

    Description of Event or Problem · 1

    THE PATIENT'S FOLLOWING PHYSICIAN IS AWARE OF THE SITUATION AND THAT THE DEVICE WAS TURNED OFF BY THE ICU. THE PATIENT HAS NOT SEEN THE PATIENT SINCE THE EVENT AND IS UNWILLING TO PROVIDE ANY ADDITIONAL INFORMATION. THEREFORE, ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN MADE BUT NO RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2015 THAT THE PATIENT IS EXPERIENCING VERY SEVERE BRADYCARDIA WITH NO EVIDENCE OF ASYSTOLE. THIS WAS DIAGNOSED ON (B)(6) ALTHOUGH IT MAY HAVE STARTED EARLIER. THE PATIENT IS SHOWING SIGNS OF ATRIAL FIBRILLATION FOLLOWED BY BRADYCARDIA AS LOW AS 20BPM. THE DEVICE WAS DEACTIVATED WITH A PACEMAKER MAGNET AND THE PATIENT SHOWED NO BRADYCARDIA AFTER THE MAGNET DEACTIVATION. THE PATIENT'S DEVICE WAS THEN DISABLED TO 0MA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345176 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 1970

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention