BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 3921787 · Received July 9, 2014

    Report

    Report Number
    2124215-2014-12825
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 16, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    PMA / PMN Number
    P010012
    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 THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WITH A COMPETITOR LEFT VENTRICULAR (LV) LEAD EXHIBITED LOSS OF CAPTURE (LOC) DUE TO HIGH, OUT OF RANGE, PACING IMPEDANCE MEASUREMENT OF MORE THAN 2,000 OHMS IN ALL VECTORS. THE HEALTH CARE PROFESSIONAL (HCP) ASKED HOW TO REPROGRAM THE DEVICE TO NOT USE THE LV LEAD. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WALKED THROUGH THE STEPS ON HOW TO REPROGRAM THE DEVICE AND ALSO WALKED THE HCP THROUGH IN TURNING THE DAILIES OFF AS REQUESTED. THE PATIENT IS UNDERGOING CHEMOTHERAPY AND WILL BE RE-EVALUATED. THE HCP BELIEVED THAT THE PATIENT'S WEIGHT LOSS OF 130 POUNDS WAS THE FACTOR IN DEVICE MEASUREMENT CHANGES. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE LV LEAD WAS TURNED OFF AND THEN EVERYTHING ELSE WENT FINE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399685 COGNIS IMPLANTABLE CHF PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR 4076| 4543| 0185| MISMATCH| N119