BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TBD

    MDR report key: 2953719 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-01343
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 11, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    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 THE INNER INSULATION WAS BREACHED CUT. IT WAS NOTED THAT THE DISTAL CONDUCTOR WAS KINKED/BUCKLED, THE PROXIMAL CONDUCTOR WAS KINKED/BUCKLED, THERE WAS BLOOD IN THE DISTAL CONDUCTOR (NOT OBSTRUCTED), THERE WAS BLOOD IN THE PROXIMAL CONDUCTOR (NOT OBSTRUCTED), THE OUTER INSULATION WAS BREACHED CUT, AND THE LEAD WAS DAMAGED AT IMPLANT. CROSS CONTINUITY FAILED DUE TO BREACHED INNER INSULATION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE R WAVE SENSING WAS LOW. THE DEVICE WAS NOT USED AND ANOTHER DEVICE WAS IMPLANTED. IT WAS ALSO REPORTED THAT DURING THE IMPLANT PROCEDURE THE LEAD COIL MALFUNCTIONED AND THAT IT WAS BROKEN. THE LEAD WAS NOT IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55969 TBD ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 457453

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR