BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE EPI

    MDR report key: 1981072 · Received February 8, 2011

    Report

    Report Number
    2182208-2011-00044
    Event Type
    Injury
    Date Received
    February 8, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P950024/S2
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    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 THE PATIENT WENT TO THE EMERGENCY ROOM COMPLAINING OF SHORTNESS OF BREATH, DIZZINESS, AND SYNCOPE. IT WAS FURTHER REPORTED THERE WAS A VENTRICULAR LEAD WARNING TRIGGERED DUE TO NOISE ON THE VENTRICULAR LEAD WITH SEVEN TO EIGHT VENTRICULAR OUTPUTS WITH FAILURE TO CAPTURE AND HIGH IMPEDANCES. ADDITIONALLY, THE ATRIAL LEAD IS FUNCTIONING NORMAL, BUT IT WAS OBSERVED ON THE X-RAY THAT THE ATRIAL LEAD MAY HAVE A FRACTURE OR CAN APPEAR TO HAVE A FRACTURE AT THE BIFURCATION. TESTING REVEALED THAT THE PATIENT FELT DIAPHRAGMATIC STIMULATION FROM THE ATRIAL LEAD. THE PACEMAKER WAS EXPLANTED AND REPLACED. THE VENTRICULAR LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE EPI IMPLANTABLE PACING LEAD DTB MEDTRONIC, INC. 4968 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization| R