BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCERTO CRT-D DR

    MDR report key: 1873711 · Received September 30, 2010

    Report

    Report Number
    6000144-2010-04277
    Event Type
    Malfunction
    Date Received
    September 30, 2010
    Date of Event
    June 17, 2009
    Report Date
    June 17, 2009
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    NIK
    PMA / PMN Number
    P10031/S0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER (B)(4) FOR A 2 YEAR RETROSPECTIVE REVIEW OF REPORTED EVENTS WHERE THE PRODUCT REMAINED IN USE; DATE RANGE 03/30/2008 AND 03/29/2010. THIS MEDWATCH REPORT REPRESENTS 1 OF 362 EVENTS (EVENT TYPE CODE MALFUNCTION). 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 OVERSENSING WAS OBSERVED WITH POCKET MANIPULATION WHILE CLOSING THE POCKET AT IMPLANT. WHEN THE DEVICE WAS REMOVED FROM THE POCKET, THE OVERSENSING COULD NOT BE REPRODUCED. WITH DEVICE BACK IN THE POCKET THEY REPORTED THE OVERSENSING HAD RESOLVED AND WAS NOT REPRODUCIBLE. THE IMPLANTING PHYSICIAN WAS SATISFIED AND CLOSED THE POCKET. THERE WERE NO PATIENT COMPLICATIONS 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 NIK MEDTRONIC PUERTO RICO, INC. C154DWK

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other