BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN ABILITY

    MDR report key: 3990776 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08484
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    February 27, 2014
    Report Date
    May 5, 2014
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE RELATED ADVERSE EVENT OR REPORTABLE PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED. THERE WAS FOREIGN MATERIAL ON THE DISTAL CONDUCTOR OF THE LEAD AND IT WAS OBSTRUCTED. GUIDEWIRE INSERTION TEST RESULT WAS FAILED. VISUAL ANALYSIS FOUND FOREIGN MATERIAL (GREEN IN COLOR AND CONFIRMED AS GUIDEWIRE'S COATING) OBSTRUCTED IN DISTAL CONDUCTOR WITH DESTRUCTIVE TESTING. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE GUIDEWIRE WOULD NOT ADVANCE OR RETRACT IN THE LEAD DURING IMPLANT BECAUSE IT WAS STUCK. THE LEAD WAS NOT USED AND ANOTHER LEAD WAS IMPLANTED. THE ATTEMPTED BUT NOT USED LEAD WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471303 ATTAIN ABILITY DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 419688

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR 5076 LEAD