BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2151306 · Received July 6, 2011

    Report

    Report Number
    2124215-2011-07133
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    April 5, 2011
    Report Date
    March 19, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBSEQUENT INFORMATION FROM THE LOCAL FIELD REPRESENTATIVE INDICATED THAT THE PATIENT WILL CONTINUE TO BE MONITORED FOR NOW. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    AS OF TODAY, THERE IS NO ADDITIONAL INFORMATION AVAILABLE AND OUR INVESTIGATION IS COMPLETE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE

    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 DEVICE AND THE ASSOCIATED RIGHT VENTRICULAR (RV) LEAD DISPLAYED A HIGH, OUT OF RANGE PACE IMPEDANCE MEASUREMENT. THERE WERE NO ADVERSE PATIENT EFFECTS WERE REPORTED. A REQUEST FOR ADDITIONAL INFORMATION HAS BEE MADE. THE DEVICE REMAINS IN SERVICE.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION INDICATED THAT THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE WHERE THE LEAD WAS SURGICALLY ABANDONED. THE DEVICE WAS EXPLANTED AND REPLACED WITH A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). THERE WERE NO ADVERSE PATIENT EFFECTS. THE LOCAL BOSTON SCIENTIFIC FIELD REPRESENTATIVE REPORTED THAT THE DEVICE WENT TO HOSPITAL PATHOLOGY AND THAT THE DEVICE WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR E102| 0147