BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILOS II DR

    MDR report key: 1851930 · Received September 23, 2010

    Report

    Report Number
    1028232-2010-02004
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    April 9, 2010
    Report Date
    August 24, 2010
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THIS DEVICE WAS RETURNED WITHOUT OOS DOCUMENTATION FROM MEDTRONIC, INC. THIS DEVICE IS IN BACKUP MODE. PER MEDTRONIC, THIS DEVICE WAS REPLACED WITH A MEDTRONIC ADDR01, (B)(4), ON (B)(6)2010.

    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 73 YR Hospitalization