BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCERTO II CRT-D

    MDR report key: 1873695 · Received September 30, 2010

    Report

    Report Number
    6000144-2010-04280
    Event Type
    Malfunction
    Date Received
    September 30, 2010
    Date of Event
    March 1, 2010
    Report Date
    March 6, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER (B)(4) FOR A 2 YEAR RETROSPECTIVE REVIEW OF REPORTED EVENTS WHERE THE PRODUCT WAS STILL IN USE; DATA RANGE 03/30/2008 AND 03/29/2010. THIS MEDWATCH REPORT REPRESENTS 1 OF 584 EVENTS (EVENT TYPE CODE MALFUNCTION). THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS BEEPING. FOLLOW-UP WITH THE PHYSICIAN'S OFFICE INDICATED THAT THE PATIENT WAS IN ATRIAL FIBRILLATION AT THE TIME OF INTERROGATION. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONCERTO II CRT-D IMPLANTABLE PACEMAKER/CARDIO/DEFIB/NIK NIK MEDTRONIC MED REL, INC. D274TRK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other 4195, IMPLANTABLE PACING LEAD| 5076, IMPLANTABLE PACING LEAD| 6949, IMPLANTABLE TACHY LEAD| 6949, IMPLANTABLE TACHY LEAD| 4195, IMPLANTABLE PACING LEAD| 5076, IMPLANTABLE PACING LEAD