BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX

    MDR report key: 4160648 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-11805
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 7, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. ELECTRICAL RESISTANCE AND CROSS CONTINUITY TEST RESULTS WERE WITHIN SPECIFICATION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD WAS REMOVED DURING THE IMPLANT PROCEDURE BECAUSE IT WAS FAULTY/MALFUNCTIONING. THE LEAD WAS NOT USED AND ANOTHER LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641474 CAPSUREFIX ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5568-53

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR