BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 1953735 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-24573
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 8, 2010
    Report Date
    December 8, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    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 DURING THE THRESHOLD TEST PORTION OF THE DEVICE INTERROGATION, RADIO FREQUENCY (RF) TELEMETRY WAS LOST WHICH CAUSED THE THRESHOLD TEST TO CONTINUE EVEN AFTER LOSS OF CAPTURE. THE BOSTON SCIENTIFIC SALES REPRESENTATIVE WAS NOT PRESENT AT THE DEVICE INTERROGATION AND STATED THAT THE CLINICIAN WAS UNAWARE THAT THE CANCEL AND END TEST BUTTONS WOULD STOP THE THRESHOLD TEST. IT WAS NOTED THAT THE PATIENT HAS COMPLETE HEART BLOCK. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)