BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PR PACING LEAD

    MDR report key: 1030541 · Received April 14, 2008

    Report

    Report Number
    1035166-2008-00008
    Event Type
    Malfunction
    Date Received
    April 14, 2008
    Date of Event
    February 1, 2008
    Report Date
    April 14, 2008
    Manufacturer
    OSCOR INC.
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LEAD REMAINS ACTIVELY IMPLANTED AS A RESULT, THE CLINICAL OBSERVATION CANNOT BE CONFIRMED. NO SERIOUS ADVERSE PT EFFECTS WERE REPORTED. THE EVENT WILL BE RE-EVALUATED IF ADDITIONAL INFO BECOMES AVAILABLE. THE DEVICE HISTORY RECORDS AND THE COMPLAINT FILES OF THE LEAD MODEL WERE REVIEWED. NO TREND OF THE SAME OR SIMILAR TYPE WAS FOUND OR INDICATED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THIS ATRIAL LEAD HAS EXHIBITED DECREASING IMPEDANCES (FROM 400 TO 250 OHMS) AND NON-CAPTURE AT 4 V. THE PT WAS NOTED WITH CHEST PAIN, AND A HISTORY OF MYOCARDIAL INFARCT. THE CLINICIAN DID NOT BELIEVE THE LEAD PERFORMANCE WAS CONTRIBUTING TO THE PT'S CURRENT MEDICAL CONDITION. RECOMMENDED UNIPOLAR TESTING WITH POCKET MANIPULATION, AND SUGGESTED CONSIDERING V VI MODE. NO SERIOUS ADVERSE PT EFFECTS WERE REPORTED. THE DEVICE REMAINS ACTIVELY IMPLANTED FOR APPROX 10 YRS, 2 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PR PACING LEAD RETRACTABLE SCREW-IN PACING LEAD DTB OSCOR INC. PR44B 3O9

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK