BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2052578 · Received April 8, 2011

    Report

    Report Number
    1644487-2011-00760
    Event Type
    Injury
    Date Received
    April 8, 2011
    Date of Event
    January 18, 2007
    Report Date
    March 25, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    EXPLORATORY SURGERY FOR THE PATIENT TO VERIFY IF THE VNS ELECTRODES ARE ALIGNED PROPERLY ON THE NERVE IS LIKELY, BUT HAS NOT OCCURRED TO DATE. IT IS ALSO POSSIBLE A NEW VNS LEAD AND GENERATOR WILL BE IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS BEEN REFERRED FOR GENERATOR AND LEAD REPLACEMENT. THE PHYSICIAN BELIEVES THAT THE ELECTRODES WERE NOT PLACED CORRECTLY DUE TO THE PATIENT SUFFERING LIFE-THREATENING BRADYCARDIA WHEN INITIALLY IMPLANTED. NO KNOWN SURGICAL INTERVENTIONS HAVE BEEN PERFORMED TO DATE.

    Description of Event or Problem · 1

    REPORTER INDICATED THAT A VNS PATIENT HAD BRADYCARDIA WITH VNS STIMULATION. THE VNS WAS DISABLED ON (B)96) 2007 AND THE BRADYCARDIA RESOLVED. THE VNS HAS BEEN DISABLED SINCE THIS DATE, AND WILL REMAIN DISABLED AT THE REPORTER'S DISCRETION. THE PATIENT DOES NOT HAVE A PRE-VNS HISTORY OF BRADYCARDIA. MEDICATION THERAPY WILL BE UTILIZED FOR THE PATIENT'S SEIZURE CONTROL. THE BRADYCARDIA WAS FELT TO BE DUE TO THE NORMAL DELIVERY OF VNS STIMULATION. IT WAS NOT KNOWN IF THE PATIENT HAD BEEN REFERRED TO A CARDIOLOGIST AT THE TIME THE BRADYCARDIA OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 015168

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention