BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 3921745 · Received July 9, 2014

    Report

    Report Number
    2124215-2014-13377
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    April 1, 2014
    Report Date
    May 28, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    PMA / PMN Number
    P960040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WITH THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH OUT-OF-RANGE (OOR) PACING IMPEDANCE GREATER THAN 2,000 OHMS VIA PATIENT'S REMOTE MONITORING SYSTEM. THE PATIENT WAS SEEN IN THE CLINIC AND WHEN DEVICE MEMORY WAS REVIEWED, FOUR HIGH OOR PACING IMPEDANCES WERE OBSERVED. FURTHER, ISOMETRICS AND POCKET MANIPULATION WAS PERFORMED AND WAS ABLE RECREATE SOME NOISE WHICH WAS MARKED AND SENSED BY THE DEVICE. IN ADDITION, THE PATIENT HAD ATRIAL FLUTTER WITH LOTS OF ATRIAL TACHY RESPONSE (ATR), WHICH WERE APPROPRIATE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED AND COULD NOT RULE OUT A LEAD OR CONNECTION ISSUE SINCE NOISE WAS HARD TO RECREATE AND NOT SEEN IN ELECTROGRAM (EGM). THE PATIENT WILL CONTINUE TO BE MONITORED. THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400133 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR 4470| T165| 1831| 4054| 0145| E110