BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOLAR ENDOCARDIAL LEAD

    MDR report key: 120486 · Received September 8, 1997

    Report

    Report Number
    2124215-1997-02299
    Event Type
    Malfunction
    Date Received
    September 8, 1997
    Date of Event
    July 8, 1997
    Report Date
    July 8, 1997
    Manufacturer
    CARDIAC PACEMAKERS
    Product Code
    DTB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT A PATIENT WITH A BIPOLAR ENDOCARDIAL LEAD (4261) SHOWED A RISE IN THE LEAD IMPEDANCE SINCE IT WAS IMPLANTED IN 07/1995, FROM 1200 OHMS TO 1970 OHMS. THEY ARE MONITORING THE PATIENT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOLAR ENDOCARDIAL LEAD Implant BIPOLAR LEAD DTB CARDIAC PACEMAKERS 4261 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other