BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP 4024

    MDR report key: 2964753 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-02107
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    November 30, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    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. CONCOMITANT PRODUCT: SDR303B PACEMAKER (B)(6) 2006. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ATRIAL AND VENTRICULAR LEAD WARNINGS WERE TRIGGERED. IT WAS NOTED THAT THERE WAS A MODE SWITCH TO UNIPOLAR PAC ING/SENSING AND THERE WAS LOW IMPEDANCE ON BOTH LEADS. NO R-WAVES WERE SEEN AT 30 BPM, VENTRICULAR SENSING WAS REPROGRAMMED TO 5.6MV TO ENSURE NO OVERSENSING IN UNIPOLAR. OVER 300 MODE SWITCHES WHICH LOOK LIKE NOISE WERE ALSO NOTED ON THE ATRIAL LEAD. BOTH LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68844 CAPSURE SP 4024 ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4024-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00098 YR Required Intervention 4504 NON-DEFIB LEAD