BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCERTO II CRT-D

    MDR report key: 1864881 · Received October 12, 2010

    Report

    Report Number
    6000144-2010-05233
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    July 28, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S125
    Removal / Correction Number
    ASKU
    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 2 EPISODES OF NOISE OCCURRED ON TWO DAYS, APRIL 29 AND JUNE 29, WITH NOISE PATTERN ON VEGM ONLY AND AEGM SHOWING CHRONIC AFIB. PATIENT WAS CHECKED FOR REAL TIME NOISE BY PERFORMING POCKET MANIPULATION AND ARM ISOMETRICS WITH NO NOISE OBSERVED. PATIENT HAS ALSO EXPERIENCED INTERMITTENT DIAPHRAGMATIC STIMULATION SINCE THE DEVICE CHANGE FROM SENTRY TO CONCERTO II. PATIENT'S LV THRESHOLDS WERE RE-PROGRAMMED ABOUT ONE WEEK AGO AND DIAPHRAGMATIC STIMULATION WAS NOT IMPROVED. THE DEVICE REMAINS IN USE. NO FURTHER 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention 4193 IMPLANTABLE PACING LEAD| 4086 COMP IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6949 IMPLANTABLE TACHY LEAD