BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM

    MDR report key: 2033746 · Received February 11, 2011

    Report

    Report Number
    1000165971-2011-00068
    Event Type
    Malfunction
    Date Received
    February 11, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 24, 2011
    Manufacturer
    SORIN CRM S.R.L.
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), 2011: THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    DURING SCHEDULED FOLLOW-UP OF THE ICD INVOLVED IN THIS REPORT, A NOISE SENSING EPISODE RECORDED IN THE IMPLANT MEMORY WAS REVIEWED. MARKERS WERE OBSERVED (WITH 125MS PERIOD) BUT THE NOISE PROTECTION FEATURE WAS NOT ACTIVATED IMMEDIATELY, REPORTEDLY. THE REPORTER ASKS FOR AN EXPLANATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADYM MRM SORIN CRM S.R.L. PARADYM CRT 8750 2387

    Patients

    Seq Age Sex Outcome Treatment
    1