BEUDAMED
    FDA Adverse Event Death Summary report: N

    REPLY

    MDR report key: 1201246 · Received October 10, 2008

    Report

    Report Number
    64901-2008-00003
    Event Type
    Death
    Date Received
    October 10, 2008
    Date of Event
    September 9, 2008
    Report Date
    October 10, 2008
    Manufacturer
    SORIN BIOMEDICA CRM S.R.L.
    Product Code
    DXY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT CONCERNS A DEVICE THAT WAS MFG AND USED OUTSIDE THE UNITED STATES. THE ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    THE PACEMAKER INVOLVED IN THIS MDR REPORT COULD NOT BE INTERROGATED, IN ADDITION, NO PACING PULSES WERE OBSERVED. THE ABSENCE OF TELEMETRY AND OUTPUT WERE OBSERVED AFTER THE PT WAS BROUGHT TO THE EMERGENCY DEPT OF THE HOSP BECAUSE OF SYNCOPES (IN 2008). THE PT CONDITIONS WORSENED IN THE FOLLOWING DAYS AND DIED AT ABOUT FIVE DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLY DXY - IMPLANTABLE CARDIAC PACEMAKER DXY SORIN BIOMEDICA CRM S.R.L. REPLY DR 2271

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death| R