BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYSTALLINE ACTIVE FIXATION

    MDR report key: 3991330 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08175
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 23, 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. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND THE HELIX OF THE LEAD BECAME EXTRINSICALLY DISTORTED DUE TO PULLING/ STRETCHING/OVERSTRESS. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANTING PROCEDURE, THE PHYSICIAN ATTEMPTED TO IMPLANT THE LEAD BUT COULD NOT PASS THROUGH TARGET VEIN. A COMPARISON OF THE USE BEFORE DATE FIELD AND IMPLANT DATE FOUND THE LEAD WAS IMPLANTED AFTER THE USE BEFORE DATE. THEN PHYSICIAN REPLACED THE LEAD WITH A DIFFERENT MODEL. WHEN THE SECOND LEAD PASSED THROUGH VALVE, THE HELIX WAS STUCK IN THE VALVE AND COULD NOT IMPLANT IN TARGET POSITION WELL. 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
    468686 CRYSTALLINE ACTIVE FIXATION ELECTRODE, PACEMAKER, PERMANENT DTB MPRI ICQ09B58

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR