BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYSTALLINE ACTIVE FIXATION

    MDR report key: 3990960 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08386
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. WHERE A SIMILAR 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 AN IMPLANT PROCEDURE, THE PHYSICIAN DROPPED THE LEAD AND COMPLAINED THE LEAD WAS NOT FIXING WELL. 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
    469864 CRYSTALLINE ACTIVE FIXATION ELECTRODE, PACEMAKER, PERMANENT DTB MPRI ICQ09B52

    Patients

    Seq Age Sex Outcome Treatment
    1