BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO CRT-D DR

    MDR report key: 1791407 · Received August 10, 2010

    Report

    Report Number
    2647346-2010-00341
    Event Type
    Injury
    Date Received
    August 10, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S031
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 NOISE ON THE ATRIAL CHANNEL PICKED UP FROM THE VENTRICULAR CHANNEL, AND THE VENTRICULAR CHANNEL ELECTROGRAM SHOWED SMALLER R-WAVES THAN THE ATRIAL. THE SENSITIVITY WAS PROGRAMMED HIGHER. DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ON AUG 8, 2010: ADDITIONAL INFORMATION RECEIVED INDICATED THE DEVICE WAS AT ELECTIVE REPLACEMENT INDICATOR AND HAD POSSIBLE PREMATURE BATTERY DEPLETION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONCERTO CRT-D DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. C154DWK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention 4194 IMPLANTABLE PACING LEAD| 6932 IMPLANTABLE TACHY LEAD