BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 3860268 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-05511
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 11, 2014
    Report Date
    March 11, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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. CONCOMITANT PRODUCT: VEDR01 IPG IMPLANTED: (B)(6) 2007. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RV (RIGHT VENTRICULAR) LEAD HAD SWITCHED POLARITY TO UNIPOLAR AND THAT THERE WAS LOW IMPEDANCE. IT WAS ALSO REPORTED THAT THE ATRIAL LEAD WOULD NOT SENSE ANY INTRINSIC ACTIVITY, AND THAT CAPTURE COULD NOT BE CONFIRMED AT MAXIMUM OUTPUT. A NEW SYSTEM WAS IMPLANTED ON THE RIGHT SIDE, WITH THE INTENT TO CAP THE OLD LEADS IN THE FUTURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342364 CAPSURE SP ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4024-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Hospitalization| R 4568-45 LEAD