BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 2954576 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-02377
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    December 20, 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
    OTHER

    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. PRODUCT: 4592 IMPLANTABLE PACING LEAD (B)(6) 1999. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD IMPEDANCE HAS BEEN TRENDING UPWARD OVERTIME AND THAT THE LEAD WILL CONTINUE TO BE MONITORED. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED POCKET STIMULATION DUE TO THE PROGRAMMING IN THE RIGHT VENTRICULAR LEAD AND ALSO EXPERIENCED WEAKNESS. IT WAS FURTHER REPORTED THAT THERE WAS HIGH IMPEDANCE, RISING IMPEDANCE OVERTIME, AND VARYING THRESHOLDS IN THE LEAD WHEN PROGRAMMED TO BIPOLAR SETTINGS. THE LEAD WAS INITIALLY REPROGRAMMED TO UNIPOLAR SETTING; HOWEVER THE PATIENT COULD NOT TOLERATE THE UNIPOLAR SETTINGS DUE TO POCKET STIMULATION. THE LEAD WAS CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57902 CAPSURE SP ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4024-52

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR