BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 1944954 · Received January 3, 2011

    Report

    Report Number
    2124215-2010-19584
    Event Type
    Injury
    Date Received
    January 3, 2011
    Date of Event
    October 5, 2010
    Report Date
    October 5, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE BOSTON SCIENTIFIC FIELD REPRESENTATIVE PRESSED THE DIVERT AND STAT PACE BUTTONS ON THE PROGRAMMER RECORDER MONITOR (PRM), BUT THIS WAS NOT UNTIL THE THRESHOLD TEST HAD ALREADY DECREMENTED PACING OUTPUT DOWN TO 0.2 V. CURRENT RECORDS SUGGEST THAT THIS DEVICE REMAINS IN SERVICE AT THIS TIME. THIS EVENT WILL BE UPDATED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THRESHOLD TESTING WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), RF TELEMETRY INTERFERENCE OCCURRED AND THE THRESHOLD TEST CONTINUED, RESULTING IN LOSS OF CAPTURE (LOC). THE PATIENT EXPERIENCED APPROXIMATELY 7 SECONDS OF ASYSTOLE AS A RESULT OF THIS OBSERVATION. THE PATIENT DID NOT PASS OUT, BUT REPORTEDLY BECAME VERY DIZZY DURING THE TEST.

    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 86 YR Life Threatening 4518| (B)(4)| 5076| N118| 4470| MISMATCH| 0185