BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCERTO II CRT-D

    MDR report key: 1925159 · Received December 14, 2010

    Report

    Report Number
    6000144-2010-06225
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    September 1, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S125
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    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

    THE PATIENT REPORTED HAVING FALLEN, AND EXPERIENCING "TERRIFIC" PAIN BETWEEN THE SHOULDER BLADE UP THROUGH THE CHEST. FURTHERMORE, WHEN THE PATIENT LAYS DOWN AT NIGHT, THE PAIN IS "HORRIFIC, ITS LIKE FIREWORKS GOING OFF IN MY CHEST". THE DEVICE IS STILL IN USE. THERE WERE NO FURTHER PATIENT COMPLICATIONS 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other 4196 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD| 4076 IMPLANTABLE PACING LEAD