BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN PERFORMA

    MDR report key: 3990761 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08490
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 6, 2014
    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

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

    Additional Manufacturer Narrative · 1

    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. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED, AND THE STYLET/GUIDEWIRE WAS KINKED/BUCKLED. THERE WAS BLOOD ON THE STY LET/GUIDEWIRE. THERE WAS BLOOD ON THE DISTAL CONDUCTOR OF THE LEAD AND IT WAS NOT OBSTRUCTED. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE PHYSICIAN WAS UNABLE TO REMOVE THE GUIDEWIRE FROM THE LEAD. THE LEAD DISLODGED AND WAS WITHDRAWN FROM THE PATIENT. THE GUIDEWIRE DID NOT ADVANCE OR WITHDRAW FROM THE LEAD WHEN PLACED ON THE SCRUB TABLE. A NEW LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471299 ATTAIN PERFORMA DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 439888

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR GWR419588, GUIDEWIRE