BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 3132290 · Received May 29, 2013

    Report

    Report Number
    1644487-2013-01614
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 1, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT DURING INITIAL VNS IMPLANT SURGERY ON (B)(6) 2013, THE PATIENT EXPERIENCED TACHYCARDIA (100-110 BPM) DURING SYSTEMS DIAGNOSTICS TESTING. THE DIAGNOSTICS WERE REPEATED WITH THE SAME RESULT. THE TACHYCARDIA ONLY OCCURRED WITH DIAGNOSTICS TESTING. THE PATIENT WAS IMPLANTED AS SCHEDULED, AND THE VNS WAS LEFT PROGRAMMED OFF. FOLLOW UP WITH THE REPORTER REVEALED THE PATIENT DOES NOT HAVE A FAMILY OR PERSONAL HISTORY OF CARDIAC EVENTS. GENERAL ANESTHESIA WAS USED DURING THE SURGERY. THE LENGTH OF THE SURGERY WAS LESS THAN ONE HOUR. THE VNS HAS BEEN PROGRAMMED ON SINCE THE SURGERY, AND THE VNS IS FUNCTIONING AS INTENDED. THE PATIENT DOES NOT HAVE ABNORMAL VAGAL ANATOMY. THE TACHYCARDIA IS FELT TO BE RELATED TO STIMULATION, BUT THE REPORTER IS UNSURE IF THIS IS DIRECTLY OR INDIRECTLY RELATED TO THE VNS STIMULATION. NO INTERVENTIONS WERE DONE OTHER THAN MAKING THE REFERRING NEUROLOGIST AWARE. NO CAUSAL OR CONTRIBUTORY PROGRAMMING CHANGES OR MEDICATION CHANGES PRECEDED THE ARRHYTHMIA. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237559 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS INC 103 202364

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other