BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALLINE ACTIVE FIXATION

    MDR report key: 5120304 · Received October 1, 2015

    Report

    Report Number
    2649622-2015-11354
    Event Type
    Injury
    Date Received
    October 1, 2015
    Date of Event
    August 18, 2015
    Report Date
    August 18, 2015
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREE DAYS AFTER IMPLANT OF THE LEAD THAT THE PATIENT WENT TO THE EMERGENCY ROOM FOR A PULMONARY EMBOLISM. THE PHYSICIAN TREATED THE PATIENT WITH A VENTILATOR AND THROMBOLYSIS. THE PHYSICIAN SUSPECTED THE HELIX CAUSED A MYOCARDIAL INJURY, "TA TROMBOKINESIS FELL OFF AND BLOCKED PULMONARY VEIN". THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647960 CRYSTALLINE ACTIVE FIXATION ELECTRODE, PACEMAKER, PERMANENT DTB MPRI ICQ09B58

    Patients

    Seq Age Sex Outcome Treatment
    1 00024 YR Hospitalization| L| R E50A1 IPG,ICQ09B52 LEAD