BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCERTO II CRT-D

    MDR report key: 2812426 · Received October 31, 2012

    Report

    Report Number
    6000144-2012-06550
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S125
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 THERE WAS AN EPISODE OF A LONG ATRIO-VENTRICULAR (AV) DELAY IN A VENTRICULAR SENSED EPISODE. THE ATRIAL LEAD SHOWED FAR FIELD R WAVE OVERSENSING THAT RESULTED IN INAPPROPRIATE DETECTION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION. THE DEVICE MODE SWITCHED AND WAS NOT TRACKING MODE DDIR SO THE AV INTERVAL WAS LONGER THAN PROGRAMMED. THE DEVICE AND ATRIAL LEAD REMAIN 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 MEDTRONIC MED REL, INC. D274TRK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other 6947 IMPLANTABLE TACHY LEAD| 4194 IMPLANTABLE PACING LEAD