BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCERTO II CRT-D

    MDR report key: 2955213 · Received February 11, 2013

    Report

    Report Number
    3004209178-2013-01869
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Report Date
    November 26, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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. CONCOMITANT PRODUCT: 4194 IMPLANTABLE PACING LEAD 2010 (B)(6), 6947 IMPLANTABLE DEFIBRILLATION LEAD 2010 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION EPISODES THAT THE DEVICE HAD NOISE ON THE ATRIAL CHANNEL AND IT WAS OVERSENSED. THERE ALSO APPEARED TO BE SOME NOISE ON THE BASELINE FOR THE RIGHT VENTRICULAR (RV) LEAD CHANNEL BUT IT WAS NOT SENSED AND THE VENTRICULAR RHYTHM WAS PACED DURING THE EPISODES. THE DEVICE AND RV 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
    58242 CONCERTO II CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO D274TRK

    Patients

    Seq Age Sex Outcome Treatment
    1 1688TC COMPETITOR IMPLANTABLE PACING LEAD