BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SP

    MDR report key: 1921316 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-12452
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    September 9, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S12
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. THE PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND REVEALED " LOW RESISTANCE/IMPEDANCE": ATRIAL LEAD WARNING RECORDED ON (B)(4) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S RIGHT ATRIAL (RA) LEAD HAD A LEAD WARNING AND THAT THE UNIPOLAR PACING IMPEDANCE WAS HIGHER THAN THE BIPOLAR IMPEDANCE. IT WAS ALSO NOTED THAT THE PATIENT'S DEVICE SWITCHED THE POLARITY OF THE LEAD. IT WAS ALSO REPORTED THAT THERE HAD BEEN SOME ATRIAL OVER SENSING WHEN THE LEAD WAS IN UNIPOLAR. THE LEAD IS STILL IN USE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE SP IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4524 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention 4024 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PULSE GENERATOR