BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN PERFORMA

    MDR report key: 4832620 · Received June 10, 2015

    Report

    Report Number
    2649622-2015-07485
    Event Type
    Malfunction
    Date Received
    June 10, 2015
    Date of Event
    April 9, 2015
    Report Date
    April 9, 2015
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. 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 AND ANALYZED AND THERE WAS BLOOD ON THE LV4 (LOW VOLTAGE 4) CONDUCTOR AND IT WAS OBSTRUCTED. THE LV4 (LOW VOLTAGE 4) CONDUCTOR WAS OBSTRUCTED DUE TO A STYLET/GUIDEWIRE STUCK IN THE LUMEN. THERE WAS BLOOD ON THE LV3 (LOW VOLTAGE 3) CONDUCTOR AND IT WAS OBSTRUCTED. THE LV3 (LOW VOLTAGE 3) CONDUCTOR WAS OBSTRUCTED DUE TO A STYLET/GUIDEWIRE STUCK IN THE LUMEN. THERE WAS BLOOD ON THE PROXIMAL CONDUCTOR. THE LV2 (LOW VOLTAGE 2)/PROXIMAL CONDUCTOR WAS OBSTRUCTED DUE TO A STYLET/GUIDEWIRE STUCK IN THE LUMEN. THERE WAS BLOOD ON THE DISTAL CONDUCTOR OF THE LEAD AND IT WAS OBSTRUCTED. THE DISTAL CONDUCTOR OF THE LEAD WAS OBSTRUCTED DUE TO A STYLET/GUIDEWIRE STUCK IN THE LUMEN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AS THE LEFT VENTRICULAR (LV) LEAD WAS BEING PLACED, THE GUIDEWIRE COULD NO LONGER BE ADVANCED FORWARD NOR WITHDRAWN. THE LEAD WAS REMOVED AND A DIFFERENT LEAD WAS SUCCESSFULLY IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376812 ATTAIN PERFORMA DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 439888

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR