BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYSTALLINE ACTIVE FIXATION

    MDR report key: 4161068 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-11650
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    June 25, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 NO ANOMALIES WERE FOUND. THE STYLET/GUIDEWIRE WAS KINKED/BUCKLED. THE DISTAL LV (LOW VOLTAGE) ELECTRODE OF THE LEAD WAS COVERED IN BLOOD. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT THE PHYSICIAN REPORTED THAT THE HELIX WOULD NOT FIXATE WELL AND THE GUIDEWIRE WOULD NOT INSERT THE LEAD TOTALLY. THE LEAD WAS REMOVED AND REPLACED WITH A NEW LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642515 CRYSTALLINE ACTIVE FIXATION ELECTRODE, PACEMAKER, PERMANENT DTB MPRI ICQ09B58

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR