BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILOS II DR

    MDR report key: 2052474 · Received March 15, 2011

    Report

    Report Number
    1028232-2011-00583
    Event Type
    Malfunction
    Date Received
    March 15, 2011
    Date of Event
    November 11, 2010
    Report Date
    March 3, 2011
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PT WAS ADMITTED TO THE ER FOLLOWING A SYNCOPE ON (B)(6) 2010. THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILOS II DR PACEMAKER NVZ BIOTRONIK SE & CO. KG 341826

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization