BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX

    MDR report key: 4831603 · Received June 10, 2015

    Report

    Report Number
    2649622-2015-05468
    Event Type
    Malfunction
    Date Received
    June 10, 2015
    Date of Event
    April 30, 2015
    Report Date
    April 30, 2015
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 MEDICAL PRODUCTS: 6945-65, LEAD, IMPLANTED: (B)(6) 1999. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS LOW IMPEDANCE. THE ATRIAL LEAD 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
    375732 CAPSUREFIX ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4568-53

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR D154AWG ICD