BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLYROX PX 53/15-BP

    MDR report key: 1883295 · Received October 22, 2010

    Report

    Report Number
    1028232-2010-02209
    Event Type
    Other
    Date Received
    October 22, 2010
    Date of Event
    September 24, 2010
    Report Date
    September 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
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BOTH MALFUNCTION AND SERIOUS INJURY.

    Description of Event or Problem · 1

    PT HAD A DEVICE CHANGE OUT LAST WEEK. AFTER THE DEVICE CHANGE OUT THE ATRIAL AND VENTRICULAR LEADS EXHIBITED PAUSES. NO CHANGES IN THRESHOLD OF IMPEDANCE WERE NOTED FOR EITHER LEAD; HOWEVER, PROVOCATIVE TESTING OF THE LEADS SHOWED NOISE ON BOTH THE ATRIAL AND THE VENTRICULAR LEADS WHEN THE PT LAID ON HER RIGHT SIDE. RECOMMENDED REPLACING THE LEADS. ON (B)(6) 2010 -BASED ON ADD'L INFO AND STRIPS, THE NOISE REPORTED WAS EXTERNAL NOISE AND THE PHYSICIAN REPROGRAMMED THE DEVICE. ON (B)(6) 2010, THIS LEAD WAS CAPPED DUE TO PACING PAUSES. THE PT ALSO HAD (B)(6) .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYROX PX 53/15-BP PACER LEAD NVZ BIOTRONIK SE & CO. KG 130050

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization