BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY DR

    MDR report key: 2212741 · Received August 16, 2011

    Report

    Report Number
    2182863-2011-00075
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    June 28, 2011
    Report Date
    July 19, 2011
    Manufacturer
    SORIN BIOMEDICA CRM S.R.L.
    Product Code
    DXY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), 2011. SINCE THE DEVICE WAS NOT RETURNED, THE PRODUCTION HISTORY AND STERILIZATION RECORDS WERE REVIEWED. THE RECORDS SHOWED THE DEVICE WAS MANUFACTURED, STERILIZED AND RELEASED ACCORDING TO APPLICABLE STANDARD OPERATING PROCEDURES. DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    AFTER 1+ MONTHS OF IMPLANTATION, THIS PACEMAKER WAS EXPLANTED DUE TO AN INFECTION. A NEW "REPLY DR" WAS 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 2505

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R