BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SP

    MDR report key: 4162902 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-12565
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    May 6, 2014
    Report Date
    July 5, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. CONCOMITANT MEDICAL PRODUCTS: 693558, LEAD, IMPLANTED: (B)(6) 2011. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REMOTE MONITORING TRANSMISSION INDICATED THAT A LEAD WARNING HAD TRIGGERED APPROXIMATELY TWO MONTHS EARLIER DUE TO LOW BIPOLAR IMPEDANCE ON THE RIGHT ATRIAL (RA) LEAD. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639672 CAPSURE SP ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4524-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00089 YR D224DRG ICD