BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 2060017 · Received April 15, 2011

    Report

    Report Number
    2124215-2011-05901
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 30, 2011
    Report Date
    September 15, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF THIS REPORT, THE LEAD REMAINS IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN PROVIDED THAT THIS IS A DEVICE SPECIFIC ISSUE, NOT A LEAD ISSUE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A LOW SHOCK IMPEDANCE MEASUREMENT WAS RECORDED. THE PATIENT WAS BROUGHT IN FOR SHOCK LEAD IMPEDANCE TESTING (SLIT) AND NORMAL IMPEDANCES WERE OBSERVED. NO RECENT SHOCK EPISODES WERE OBSERVED. TECHNICAL SERVICES RECOMMENDED DOING A MAX ENERGY SHOCK TEST TO DETERMINE IF THERE IS A SHORTED CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N118

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR 4461| 4518| (B)(4)| 4464| 0145| 0144| 4136| N118| 1853| 0185