BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLY DR

    MDR report key: 1911686 · Received December 1, 2010

    Report

    Report Number
    2182863-2010-00117
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Date of Event
    October 26, 2010
    Report Date
    November 2, 2010
    Manufacturer
    SORIN BIOMEDICA CRM S.R.L.
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2010. THE ANALYSIS ON THIS DEVICE IS PENDING. (B)(4) 2011.

    Additional Manufacturer Narrative · 1

    DECEMBER 1, 2010. THE ANALYSIS ON THIS DEVICE IS PENDING.

    Description of Event or Problem · 1

    DURING THE IMPLANTATION PROCEDURE, THE DEVICE WOULD NOT SENSE OR PACE APPROPRIATELY IN THE POCKET AND UPON PLACEMENT OF LEADS. IT WAS REPORTED THAT THE DEVICE COULD BE INTERROGATED AND THE USE OF IECG WAS SUCCESSFUL OUTSIDE THE POCKET. THIS DEVICE WAS NOT IMPLANTED, A NEW SYMPHONY WAS SUCCESSFULLY IMPLANTED.

    Description of Event or Problem · 1

    DURING THE IMPLANTATION PROCEDURE, THE DEVICE WOULD NOT SENSE OR PACE APPROPRIATELY IN THE POCKET AND UPON PLACEMENT OF LEADS. IT WAS REPORTED THAT THE DEVICE COULD BE INTERROGATED AND THE USE OF IECG WAS SUCCESSFUL OUTSIDE THE POCKET. THIS DEVICE WAS NOT IMPLANTED, A NEW SYMPHONY WAS SUCCESSFULLY IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLY DR CARDIAC PACEMAKER DXY SORIN BIOMEDICA CRM S.R.L. REPLY DR

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR