BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 1862857 · Received October 9, 2010

    Report

    Report Number
    2649622-2010-10480
    Event Type
    Injury
    Date Received
    October 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
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL AND RIGHT VENTRICULAR LEADS WERE SUSPECTED TO HAVE INSULATION PROBLEMS AS THE UNIPOLAR IMPEDANCE WAS HIGHER THAN THE BIPOLAR IMPEDANCE. IT WAS ALSO REPORTED THAT THE BIPOLAR IMPEDANCE WAS LOW FOR BOTH LEADS. THE RIGHT VENTRICULAR LEAD ONLY CAPTURED IN UNIPOLAR CONFIGURATION AT HIGH OUTPUT. THE ATRIAL LEAD HAD HIGH THRESHOLDS. BOTH LEADS WERE CAPPED AND REPLACED. 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 SP IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4024 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention 7860B IMPLANTABLE PULSE GENERATOR