BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX

    MDR report key: 3153547 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-06075
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 30, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND THE DISTAL CONDUCTOR OF THE LEAD WAS EXTRINSICALLY OVER-ROTATED. THE DISTAL CONDUCTOR WAS EXTRINSICALLY DISTORTED DUE TO KINKING/BUCKLING. THE DISTAL LV (LOW VOLTAGE) ELECTRODE OF THE LEAD WAS COVERED IN BLOOD AND THE HELIX OF THE LEAD WAS EXTRINSICALLY COMPRESSED. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT. THE ANALYST COMMENTED THE LEAD WAS RECEIVED WITH THE HELIX OVER RETRACTED, AND DISTORTION OF THE DISTAL CONDUCTOR WITHIN THE IS-1 CONNECTOR. THIS IS INDICATIVE OF THE CONNECTOR PIN BEING TURNED AN EXCESSIVE NUMBER OF TIMES DURING HELIX RETRACTION. ELECTRICAL AND CROSS CONTINUITY TEST RESULTS WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, HIGH THRESHOLDS WERE MEASURED ON THE ATRIAL LEAD. THE SCREW WAS RETRACTED AND REPOSITIONED IN A DIFFERENT LOCATION. AT THE SECOND POSITION, THE SCREW DID NOT COME OUT AT ALL, EVEN AFTER EXCESSIVE NUMBER OF TURNS. THE LEAD WAS ATTEMPTED AND NOT USED. ANOTHER LEAD WAS USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256889 CAPSUREFIX ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5568-53

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR