BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN PERFORMA

    MDR report key: 3991418 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08119
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    December 3, 2013
    Report Date
    May 6, 2014
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED, AND THERE WAS BLOOD ON THE DISTAL CONDUCTOR OF THE LEAD AND IT WAS OBSTRUCTED. THE ANALYST COMMENTED THAT THE LEAD WAS RETURNED WITH THE GUIDEWIRE STUCK IN THE LEAD. THERE WAS DRIED BLOOD OBSERVED IN THE LUMEN OF THE LEAD. IT IS LIKELY THAT THE GUIDE WIRE BECAME STUCK AFTER THE BLOOD INGRESSED AND THEN DRIED DURING THE PROCEDURE. THE GUIDEWIRE WAS REMOVED USING DESTRUCTIVE ANALYSIS.

    Additional Manufacturer Narrative · 1

    THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES; HOWEVER, IT IS SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S. THIS EVENT OCCURRED OUTSIDE THE US AND PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT THE GUIDEWIRE BECAME STUCK IN THE LEFT VENTRICULAR (LV) LEAD. THE LEAD WAS NOT USED AND WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470010 ATTAIN PERFORMA DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 429888

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR