BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX

    MDR report key: 2864925 · Received December 10, 2012

    Report

    Report Number
    2649622-2012-17562
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Report Date
    October 25, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE 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 PRODUCT: 4092 NON DEFIB LEAD (B)(6) 1999. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS LOW ATRIAL LEAD IMPEDANCE AND INCONSISTENT ATRIAL SENSING. 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
    1 CAPSUREFIX ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4068

    Patients

    Seq Age Sex Outcome Treatment
    1 00087 YR (B)(4) PACEMAKER