BEUDAMED
    FDA Adverse Event Other Summary report: N

    ESTELLA SR-T

    MDR report key: 2141553 · Received June 17, 2011

    Report

    Report Number
    1028232-2011-01345
    Event Type
    Other
    Date Received
    June 17, 2011
    Date of Event
    May 16, 2011
    Report Date
    June 9, 2011
    Manufacturer
    BIOTRONIK SE & CO. KG.
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OUS MDR.

    Description of Event or Problem · 1

    OUS MDR. AFTER AN IMPLANTATION TIME OF APPROX 3 DAYS, AN EXIT BLOCKAGE WAS REPORTED AND THE PACEMAKER KEPT PACING IN A BIPOLAR MANNER, DESPITE THE UNIPOLAR LEAD. THE PACEMAKER WAS THEN REPROGRAMMED TO UNIPOLAR MODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESTELLA SR-T PACEMAKER NVZ BIOTRONIK SE & CO. KG. 371200

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention