BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 3070508 · Received April 22, 2013

    Report

    Report Number
    1644487-2013-01101
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 26, 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

    REPORTER INDICATED THAT DURING INITIAL VNS IMPLANTATION SURGERY UNDER GENERAL ANESTHESIA, THE PATIENT EXPERIENCED ASYSTOLE DURING VNS SYSTEMS DIAGNOSTICS TESTING. A 2ND SYSTEMS DIAGNOSTICS TEST WAS PERFORMED AND ASYSTOLE DID NOT OCCUR, BUT THE PATIENT'S HEART RATE DID DECREASE SLIGHTLY. THE PATIENT DOES HAVE A PRE-VNS HISTORY OF CARDIAC EVENTS, BUT THE EVENTS ARE NOT PROVIDED. THE PATIENT HAS NO FAMILY HISTORY OF CARDIAC EVENTS, HAS NO PRE-EXISTING MEDICAL CONDITIONS, AND DOES NOT HAVE ABNORMAL VAGAL ANATOMY. THE ASYSTOLE EVENT IS BELIEVED TO BE RELATED TO VNS STIMULATION. THE PATIENT DID NOT PRESENT WITH ANY SYMPTOMS SUGGESTING AN ARRHYTHMIA, DID NOT EXPERIENCE ANY TRAUMATIC EVENTS PRIOR TO THE ARRHYTHMIA, AND DID NOT HAVE ANY TRIGGERS PRIOR TO THE ARRHYTHMIA. THE ASYSTOLE DID NOT OCCUR FOLLOWING A MEDICATION CHANGE. THE ASYSTOLE EVENT DID CORRELATE WITH THE STIMULATION ON TIME DURING SYSTEMS DIAGNOSTICS AND NOT DURING A SETTING CHANGE. THE ASYSTOLE EVENT IS FELT TO BE RELATED TO STIMULATION AND CONTRIBUTED TO THE ARRHYTHMIA. THE VNS WAS DISABLED AS AN INTERVENTION. THE GENERATOR IS NOT CURRENTLY PROGRAMMED ON, AND THE ASYSTOLE EVENT HAS NOT RECURRED. THE REPORTER ALSO STATED "PATIENT TOLERATED 0.25MA STIMULATION FOR 10 MINUTES INTRAOPERATIVELY. PATIENT SHOULD BE IN A MONITORED SETTING FOR ANY STIMULATION ADJUSTMENTS AT LEAST FIRST TWO."

    Description of Event or Problem · 1

    REPORTER INDICATED THE PATIENT'S VNS HAS BEEN ACTIVATED AND THE CURRENT OUTPUT CURRENT IN 0.5MA. THE PATIENT IS DOING WELL AT THIS TIME AND TOLERATING VNS STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173197 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS INC 103 202296

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention