BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN PERFORMA

    MDR report key: 3860004 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-05632
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    March 20, 2014
    Report Date
    March 20, 2014
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED MALFUNCTION. PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND THERE WAS BLOOD ON THE DISTAL CONDUCTOR OF THE LEAD AND IT WAS OBSTRUCTED. THERE WAS BLOOD ON THE PROXIMAL CONDUCTOR OF THE LEAD AND IT WAS OBSTRUCTED. THE DISTAL AND PROXIMAL CONDUCTORS OF THE LEAD WERE OBSTRUCTED BY THE STYLET/GUIDWIRE. THERE WAS BLOOD ON THE LOW VOLTAGE 3 AND 4 CONDUCTORS AND THEY WERE OBSTRUCTED. THE LOW VOLTAGE 3 AND 4 CONDUCTORS WERE OBSTRUCTED BY THE STYLET/GUIDWIRE. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT. LEAD RECEIVED WITH THE GUIDEWIRE WAS STUCK IN IT. AT THE TIME OF ANALYSIS WHEN TRYING TO PULL IT OUT, THE GUIDEWIRE UNRAVELED AND COULD NOT BE REMOVED. VISUAL INSPECTION FOUND BLOOD OBSTRUCTION IN THE LUMEN. NO DISTORTION OR BUCKLING OF THE CONDUCTORS, HOWEVER, THERE IS A LOT OF BLOOD AT DISTAL END WITHIN 20CM OF THE LEAD CAUSING THE GUIDEWIRE TO BE STUCK INSIDE THE LEAD. PERFORMED DESTRUCTIVE ANALYSIS, REMOVED THE GUIDEWIRE THEN COMPLETED TESTS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE GUIDEWIRE GOT STUCK IN THE LEAD WHEN TRYING TO GET THE WIRE IN A SIDE BRANCH OF THE CORONARY SINUS. THE LEAD WAS NOT IMPLANTED AND 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
    340691 ATTAIN PERFORMA DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 459888

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR