BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADYM

    MDR report key: 3133626 · Received May 24, 2013

    Report

    Report Number
    1000165971-2013-00265
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 3, 2013
    Manufacturer
    SORIN GROUP ITALIA S.R.L.
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2013. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    DURING THE TWO DAYS AFTER IMPLANTATION, SUBJECT DEVICE HAD SEVERAL RESETS. PRELIMINARY ANALYSIS REVEALED NORMAL OPERATION OF THE DEVICE COULD NOT BE GUARANTEED. THE DEVICE WAS REPLACED AND RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232260 PARADYM MRM SORIN GROUP ITALIA S.R.L. PARADYM RF DR 9550 2686

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention