BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 2810529 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16003
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S12
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. EVALUATION SUMMARY (B)(4) - THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LEAD WARNING FOR BOTH THE ATRIAL AND VENTRICULAR LEADS FOR IMPEDANCE MEASUREMENTS THAT HAVE BEEN DECREASING AND ARE NOW LOW. IT WAS NOTED THAT THE VENTRICULAR LEAD UNIPOLAR IMPEDANCE WAS HIGHER THAN THE BIPOLAR IMPEDANCE. BOTH LEADS WERE CAPPED AND REPLACED. THE PATIENT ALSO HAD COMPLAINT OF "NOT FEELING WELL" SINCE THE DEVICE WENT TO ELECTIVE REPLACEMENT INDICATOR. IT WAS THOUGHT THAT THIS WAS DUE TO PACEMAKER SYNDROME. THE DEVICE WAS EXPLANTED 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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R