BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2518688 · Received April 5, 2012

    Report

    Report Number
    2124215-2012-00179
    Event Type
    Malfunction
    Date Received
    April 5, 2012
    Date of Event
    November 7, 2011
    Report Date
    January 3, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS BOSTON SCIENTIFIC DEVICE AND COMPETITOR RIGHT ATRIAL (RA) LEAD WAS EXHIBITING VARIABLE PACING IMPEDANCE (500-1800 OHMS) OVER SEVERAL MONTHS. ALTHOUGH, THE RA PACING PERCENTAGE WAS LESS THAN ONE PERCENT, THE RA PACING THRESHOLD WAS ELEVATED AT 2.9 VOLTS AT 1.0 MS. THERE WAS NO PLAN FOR ANY INVASIVE INTERVENTION AT THIS TIME. THE RIGHT VENTRICULAR (RV) LEAD DIAGNOSTIC MEASUREMENTS WERE NORMAL. THE RA SENSITIVITY WAS REPROGRAMMED FROM 0.25 MV TO 1.0 MV. DURING THE FOLLOW-UP CHECK, THE PATIENT BECAME VERBALLY ABUSIVE AND MADE PHYSICAL THREATS AGAINST THE LOCAL REPRESENTATIVE IF ANY DEVICE/LEAD ISSUES WERE IDENTIFIED. THE LOCAL REPRESENTATIVE REPORTED THE PATIENT'S BEHAVIOR TO THE CLINIC NURSE AND PHYSICIAN. BOSTON SCIENTIFIC'S LEGAL DEPARTMENT WAS NOTIFIED OF THIS LOCAL REPRESENTATIVE'S ENCOUNTER WITH THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR 0185| E110| 5076