BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADYM

    MDR report key: 1870701 · Received October 8, 2010

    Report

    Report Number
    1000165971-2010-00931
    Event Type
    Death
    Date Received
    October 8, 2010
    Date of Event
    August 12, 2010
    Report Date
    September 15, 2010
    Manufacturer
    SORIN BIOMEDICA CRM S.R.L.
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON 10/08/2010. THIS EVENT CONCERNS A DEVICE THAT WAS MFG AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    REPORTEDLY, THE PT PASSED AWAY. IT WAS REPORTED THAT HE HAD A RHYTHMIC STORM BEFORE DEATH BUT THE CAUSE OF THE DEATH WAS NOT RELATED TO THE ICD INVOLVED IN THIS MDR REPORT. HOWEVER, THE DEVICE WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADYM MRM SORIN BIOMEDICA CRM S.R.L. PARADYM CRT 8750 2443

    Patients

    Seq Age Sex Outcome Treatment
    1 Death