BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SP

    MDR report key: 4831458 · Received June 10, 2015

    Report

    Report Number
    2649622-2015-05550
    Event Type
    Malfunction
    Date Received
    June 10, 2015
    Date of Event
    May 10, 2010
    Report Date
    April 14, 2015
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    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 MEDICAL PRODUCTS: 4024-58 LEAD, IMPLANTED: (B)(6) 2000. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD TRIGGERED A WARNING FOR MEASURED LOW PACING IMPEDANCE. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD SHOWED A POLARITY SWITCH TO UNIPOLAR. THE RV LEAD ALSO MEASURED LOW PACING IMPEDANCE. THE LEADS REMAINS 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
    375615 CAPSURE SP ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4524-53

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR ADDR01 IPG