BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM

    MDR report key: 2093319 · Received April 15, 2011

    Report

    Report Number
    1000165971-2011-00168
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    February 9, 2011
    Report Date
    April 1, 2011
    Manufacturer
    SORIN CRM S.R.L.
    Product Code
    MRM
    PMA / PMN Number
    P060027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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

    THE ICD INVOLVED IN THIS REPORT WAS IMPLANTED ON (B)(6) 2010. DURING A SCHEDULED FOLLOW-UP ON (B)(6) 2011, THE PHYSICIAN OBSERVED SEVERAL NOISE SENSING EPISODES RECORDED IN THE ICD MEMORIES. ANALYSIS AND SUGGESTIONS WERE REQUESTED. NO INAPPROPRIATE THERAPY OCCURRED AS A RESULT OF THIS NOISE SENSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADYM MRM SORIN CRM S.R.L. PARADYM CRT 8750 2446

    Patients

    Seq Age Sex Outcome Treatment
    1