BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SENSE

    MDR report key: 1791871 · Received August 10, 2010

    Report

    Report Number
    2182208-2010-00432
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    March 10, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S034
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY (B)(4) THE FULL LEAD RETURNED AND ANALYZED. PRIMARY ANALYSIS FINDING: NO ANOMALIES FOUND. LEAD MODEL 4574: THE MANUFACTURING DATE CANNOT BE CONFIRMED WITHOUT THE DEVICE SERIAL NUMBER.

    Description of Event or Problem · 1

    THE REPORT INDICATED DURING THE IMPLANT PROCEDURE, LEAD IMPEDANCE WAS HIGHER THAN 2000 OHMS AND WAS ABNORMAL AFTER SEVERAL TRIES. THEREFORE, THE LEAD WAS WITHDRAWN. A SECOND LEAD WAS UNSUCCESSFULLY ATTEMPTED, AS THE SAME PROBLEM OCCURRED, AND CONSEQUENTLY, THIS LEAD WAS WITHDRAWN AS WELL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE SENSE IMPLANTABLE PACING LEAD DTB MEDTRONIC, INC. 4574 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 88 Required Intervention