BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 2913234 · Received January 14, 2013

    Report

    Report Number
    2124215-2013-00142
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 12, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS CURRENTLY AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS OF GREATER THAN 2000 OHMS. AN X-RAY REVEALED A POSSIBLE FRACTURE AND THAT THE PIN OF THE LV LEAD WAS NOT SEATED ALL THE WAY PAST THE CONNECTOR BLOCK IN THE DEVICE HEADER. AN EMAIL WAS SENT TO THE FIELD REPRESENTATIVE IN AN ATTEMPT TO OBTAIN RESOLUTION TO THIS ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20692 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR 4086| H170| 4542| N119| 0185