BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2041170 · Received March 29, 2011

    Report

    Report Number
    1644487-2011-00659
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    February 28, 2011
    Report Date
    February 28, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT DURING VNS IMPLANT SURGERY THE PT EXPERIENCED AN EPISODE OF BRADYCARDIA DURING SYSTEMS DIAGNOSTICS TESTING. THE HEART RATE DROPPED FROM 105 TO 40-70 AND THEN REBOUNDED BACK TO 110. THE SYSTEMS DIAGNOSTICS TEST WAS REPEATED AGAIN AND THE HEART RATE DROPPED TO 100. THE REPORTER VERIFIED THE VNS LEAD WAS IMPLANTED NORMALLY ON THE LEFT VAGUS NERVE, AND THE PT HAD NORMAL VAGUS ANATOMY. THE VNS WAS LEFT DISABLED AT THE SURGERY TO PRECLUDE A SERIOUS INJURY. NO INTERVENTIONS WERE DONE FOR THE INTRAOPERATIVE BRADYCARDIA EPISODE. THE REPORTER ATTRIBUTED THE BRADYCARDIA TO THE SYSTEMS DIAGNOSTICS TESTING. THE PT HAD NO PREVIOUS HISTORY OF CARDIAC EVENTS. THE PT WAS NOT HOSPITALIZED NOR WAS HOSPITALIZATION PROLONGED AS A RESULT OF THE BRADYCARDIA. FOLLOW UP WITH THE ATTENDING NEUROLOGIST'S OFFICE REVEALED THE PT'S VNS HAS BEEN TURNED ON AND THE PT HAS HAD NO MORE EPISODES OF BRADYCARDIA TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 LYJ CYBERONICS, INC. 103 2773

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Required Intervention