BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN OTW

    MDR report key: 2952548 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00610
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 19, 2012
    Report Date
    November 19, 2012
    Manufacturer
    MPRI
    Product Code
    LWP
    PMA / PMN Number
    P010015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    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 (B)(4): THE FULL LEAD WAS RETURNED AND ANALYZED. THE LEAD INSULATION WAS BREACH (EXTRINSIC) INNER INSULATION STYLET/GUIDEWIRE. VISUAL ANALYSIS NOTED THERE WAS DAMAGED AT IMPLANT. ATTEMPTED GUIDEWIRE TEST USING THE RETURNED GUIDEWIRE, BUT IT IS DAMAGED TOO MUCH; TEST FAILED. USED A FRESH .014 INCH COUGAR XT AND TEST PASSED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE LEAD WAS OBSERVED WITH INSULATION DAMAGE WHEN BACK LOADING THE LEAD OVER THE GUIDE WIRE. THE LEAD WAS NOT IMPLANTED AND WAS REPLACED WITH A NEW LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS THE RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57343 ATTAIN OTW PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MPRI 419478

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR