BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO CRT-D DR

    MDR report key: 1924542 · Received December 14, 2010

    Report

    Report Number
    6000144-2010-06149
    Event Type
    Injury
    Date Received
    December 14, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S031
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 THE LEFT VENTRICULAR PACING POLARITY WAS REPROGRAMMED AND THE LEFT VENTRICULAR LEAD IMPEDANCE DECREASED FROM 600 TO 300 OHMS. IT WAS ALSO REPORTED THAT THE DEVICE DISPLAYED NOISE ON THE ATRIAL AND VENTRICULAR CHANNELS, POSSIBLY DUE TO ELECTRO-MAGNETIC INTERFERENCE. BOTH THE LEAD AND DEVICE ARE STILL 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 CRT-D DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. C154DWK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other| R 6942 IMPLANTABLE TACHY LEAD| 6940 IMPLANTABLE PACING LEAD