BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM

    MDR report key: 3202224 · Received June 28, 2013

    Report

    Report Number
    1000165971-2013-00319
    Event Type
    Malfunction
    Date Received
    June 28, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 19, 2013
    Manufacturer
    SORIN GROUP ITALIA S.R.L.
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING A REGULAR FOLLOW-UP OF THE SUBJECT DEVICE ON (B)(6) 2013, THE DEVICE MEMORIES (AIDA) WERE FOUND EMPTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296497 PARADYM MRM SORIN GROUP ITALIA S.R.L. PARADYM DR 8550 2634

    Patients

    Seq Age Sex Outcome Treatment
    1