BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSCOR

    MDR report key: 163645 · Received April 17, 1998

    Report

    Report Number
    MW1013553
    Event Type
    Injury
    Date Received
    April 17, 1998
    Date of Event
    September 4, 1997
    Report Date
    April 14, 1998
    Manufacturer
    SULZER INTERMEDICS, INC.
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    OSCOR RX58TBV VENTRICULAR LEAD DISPLAYED A GRADUAL DECLINE IN BIPOLAR RESISTANCE FROM PREDOMINANTLY 900-1077 OHMS THE FIRST AND SECOND YEARS POST IMPLANT. THROUGH-OUT 1995 THE RESISTANCE MEASURED FROM 642-808 OHMS, WITH EXCELLENT STABLE CAPTURE THRESHOLDS, BUT SENSING THRESHOLD WAS DETERIORATING. FROM 02-08-96 THE RESISTANCE FURTHER DROPPED FROM 693 OHMS TO 528 OHMS ON 09/26/96 WITH NO FURTHER CHANGE IN PERFORMANCE. ON 01/17/97 481 OHMS WERE MEASURED, AND ON 5/2/97 449 OHMS. THE PERFORMANCE REMAINED STABLE. THE LEAD FAILED ON 9/4/97 WITH TOTAL NON-CAPTURE AND A BIPOLAR RESISTANCE OF 180 OHMS. THE LEAD WAS SURGICALLY REPLACED ON 9/9/97 DUE TO BIPOLAR INSULATION FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSCOR Implant VENTRICULAR PACEMAKER LEAD DTB SULZER INTERMEDICS, INC. RX58TBV *

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| L| R