BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN ABILITY

    MDR report key: 3221124 · Received July 11, 2013

    Report

    Report Number
    2649622-2013-08198
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    June 3, 2013
    Report Date
    November 7, 2013
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY #PRODUCT ID# 419688, THE FULL LEAD WAS RETURNED. THE DISTAL CONDUCTOR OF THE LEAD BECAME EXTRINSICALLY FRACTURED DUE TO PULLING/STRETCHING/OVERSTRESS, THE OUTER INSULATION OF THE LEAD WAS EXTRINSICALLY BREACHED DUE TO A CUT, VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT, VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED STRETCHING.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THERE WAS DIFFICULTY GETTING THE WIRE OUT OF THE LEFT VENTRICULAR (LV) LEAD AND IT WAS NOTED THAT THERE WAS A KINK IN THE WIRE THAT WAS AROUND THE SUTURE SLEEVE. AFTER TAKING THE SUTURES OUT OF THE WIRE THE LV LEAD WAS NOTED TO HAVE HIGH IMPEDANCE AND THE INSULATION APPEARED TO BE DAMAGED. THE LV LEAD WAS REMOVED AND REPLACED WITH A NEW LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319799 ATTAIN ABILITY DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 419688

    Patients

    Seq Age Sex Outcome Treatment
    1 00001 MO