BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 1952192 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-23384
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    December 3, 2010
    Report Date
    February 22, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE PRODUCT REMAINS IN SERVICE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED AS NECESSARY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT WAS UNDERGOING A DERMATOLOGY PROCEDURE, WHEN SHE FELT LIGHTHEADED AND PASSED OUT. THE DEVICE INDICATED THERE WAS NOISE PRESENT AS WELL AS OVERSENSING AND PACING INHIBITION OF GREATER THAN 2 SECONDS. TECHNICAL SERVICES WAS CONSULTED AND STATED THAT IT WAS MOST LIKELY THE CAUTERY EQUIPMENT MAY HAVE BEEN CAUSING INTERFERENCE WITH THE DEVICE. AND DURING THE NEXT SESSION IN THE DERMATOLOGISTS OFFICE, THE DEVICE SHOULD BE PLACED IN CAUTERY MODE WHICH WILL ALLEVIATE SOME OF THE SYMPTOMS. TO DATE, THERE HAVE BEEN NO ADDITIONAL ADVERSE PATIENT EFFECTS 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 79 YR Other 5024M| 4004| 294-03| 4194| 4058M| N119| 6949| 7299| 284-05| MISMATCH