BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM

    MDR report key: 2033805 · Received February 11, 2011

    Report

    Report Number
    1000165971-2011-00076
    Event Type
    Malfunction
    Date Received
    February 11, 2011
    Date of Event
    January 21, 2011
    Report Date
    January 31, 2011
    Manufacturer
    SORIN CRM S.R.L.
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN ASSISTANT

    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

    REPORTEDLY, ON (B)(6) 2011, THE AIDA DEVICE HOLTER MEMORY WERE NOT AVAILABLE. THE PHYSICIAN ASKED WHY THE DEVICE MEMORY WERE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADYM MRM SORIN CRM S.R.L. PARADYM CRT 8750 2487

    Patients

    Seq Age Sex Outcome Treatment
    1