BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 3922056 · Received July 9, 2014

    Report

    Report Number
    2124215-2014-13439
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 7, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 VIA THE PATIENT REMOTE MONITORING SYSTEM THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW OUT-OF-RANGE SHOCK LEAD IMPEDANCE (SLI) MEASUREMENT OF 0 OHMS. THE PATIENT WAS IN SURGERY THE TIME OF THE 0 OHMS IMPEDANCE DETECTED. SUBSEQUENTLY, BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) STATED THAT SURGERY LIKELY THE CAUSE OF THE ELECTROMAGNETIC INTERFERENCE (EMI). RECENT UPLOAD OF THE PATIENT SHOCK IMPEDANCE SHOWED 40 OHMS. ADDITIONAL INFORMATION WAS RECEIVED THAT NO FURTHER ACTION WAS NEEDED. AT THIS TIME, THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401637 COGNIS IMPLANTABLE CHF PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR 4136| 0185| 4592| 4555| N119