BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADYM

    MDR report key: 4250933 · Received November 14, 2014

    Report

    Report Number
    1000165971-2014-00627
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    October 17, 2014
    Report Date
    October 17, 2014
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    MRM
    PMA / PMN Number
    PP060027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRELIMINARY ANALYSIS OF THE RETURNED DEVICE CONFIRMED IT OPERATED AS SPECIFIED.

    Description of Event or Problem · 1

    SYSTEM EXPLANTED DUE TO INFECTION. DEVICE WAS RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    SYSTEM EXPLANTED DUE TO INFECTION. DEVICE WAS RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    SYSTEM EXPLANTED DUE TO INFECTION. DEVICE WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737986 PARADYM DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER MRM SORIN GROUP ITALIA S.R.L. - CRM FACILITY PARADYM RF VR 9250 2741

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R