BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 3030482 · Received April 2, 2013

    Report

    Report Number
    1644487-2013-00885
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    May 17, 2011
    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 Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT BRADYCARDIA WAS SEEN DURING IMPLANT. ON (B)(6) 2011, THE EVENT APPEARED TEMPORARILY AND ONLY ONCE WHEN THE TEST STIMULATION WAS ON. TEST STIMULATION WAS APPLIED THREE ADDITIONAL TIMES, AND NO BRADYCARDIA OCCURRED. THE OPERATION WAS COMPLETED SUCCESSFULLY. NO INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(4) 2013. THE BRADYCARDIA OCCURRED ON SYSTEM DIAGNOSTICS IN IMPLANT SURGERY (1MA, 500 USEC). A LOWER LEVEL OF SYSTEM DIAGNOSIS (0.25MA, 130USEC) DID NOT MAKE BRADYCARDIA. THE STIMULATION WAS GRADUALLY INCREASED AND THE EVENT DID NOT OCCUR AGAIN. THE IMPLANT SURGERY WAS CONTINUED. THE PATIENT DOES NOT HAVE A PERSONAL OR FAMILIAL HISTORY OF CARDIAC EVENTS. THE EVENT OCCURRED ON (B)(6) 2011 DURING SYSTEM DIAGNOSTICS, THE RESULTS OF WHICH WERE NORMAL. GENERAL ANESTHESIA WAS USED. THE PATIENT WAS NOT ON ANY OTHER MEDICATIONS AT THE TIME. THE DURATION OF SURGERY WAS FIVE HOURS AND ONE MINUTE. THE PATIENT DOES NOT HAVE ANY ABNORMAL VAGAL ANATOMY. THE DEVICE WAS FUNCTIONING APPROPRIATELY. NO INTERVENTIONS WERE TAKEN. THE CURRENT DEVICE SETTINGS HAVE ALSO BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134054 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 2665

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other