BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM

    MDR report key: 4163470 · Received October 10, 2014

    Report

    Report Number
    1000165971-2014-00570
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    October 7, 2014
    Report Date
    October 9, 2014
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    MRM
    PMA / PMN Number
    PP060027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DIFFICULTIES WERE ENCOUNTERED DURING INDUCTION TESTS PERFORMED ON (B)(6) 2014.

    Description of Event or Problem · 1

    DIFFICULTIES WERE ENCOUNTERED DURING INDUCTION TESTS PERFORMED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640411 PARADYM DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER MRM SORIN GROUP ITALIA S.R.L. - CRM FACILITY PARADYM RF DR 9550 2777

    Patients

    Seq Age Sex Outcome Treatment
    1