BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX

    MDR report key: 3860003 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-05627
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    March 27, 2014
    Report Date
    March 27, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED. THE DISTAL CONDUCTOR OF THE LEAD WAS EXTRINSICALLY OVER-ROTATED. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED STRETCHING AND DAMAGE AT IMPLANT.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, THE PHYSICIAN ATTEMPTED TO FIXATE THE ATRIAL LEAD, BUT WAS UNSUCCESSFUL. THE LEAD WAS REMOVED AND TESTED ON THE TABLE, AND A HELIX ISSUE WAS OBSERVED. 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
    340142 CAPSUREFIX ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5568-53

    Patients

    Seq Age Sex Outcome Treatment
    1 00043 YR