BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM

    MDR report key: 2833463 · Received October 26, 2012

    Report

    Report Number
    1000165971-2012-00412
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Date of Event
    October 11, 2012
    Report Date
    October 17, 2012
    Manufacturer
    SORIN CRM S.R.L.
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2012: THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS PENDING.

    Description of Event or Problem · 1

    REPORTEDLY, DURING A SCHEDULED FOLLOW-UP PERFORMED ON (B)(6) 2012, A STRANGE UNEXPECTED BATTERY CURVE WAS OBSERVED. AN EXPLANTATION IS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADYM MRM SORIN CRM S.R.L. PARADYM VR 8250 2587

    Patients

    Seq Age Sex Outcome Treatment
    1