BEUDAMED
    FDA Adverse Event Other Summary report: N

    PHILOS II DR-T

    MDR report key: 1883303 · Received October 22, 2010

    Report

    Report Number
    1028232-2010-02378
    Event Type
    Other
    Date Received
    October 22, 2010
    Date of Event
    September 24, 2010
    Report Date
    October 21, 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
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) .

    Description of Event or Problem · 1

    ON (B)(6) 2010, (B)(4) WAS CONTACTED REGARDING NOISE AND PACING PAUSES ON BOTH LEADS FOR THIS PT. THE PHYSICIAN CANNOT DETERMINE IF THE PACING PAUSES WERE CAUSED BY THE LEADS OR THE DEVICE, SO THE ENTIRE SYSTEM WAS REMOVED FROM SERVICE ON (B)(6) 2010. THE PT ALSO HAD (B)(6) . THIS DEVICE WAS DISCARDED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILOS II DR-T PACEMAKER NVZ BIOTRONIK SE & CO. KG 343175

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization