BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY

    MDR report key: 3992715 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09708
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 16, 2014
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE ON THE LV (LEFT VENTRICULAR) PACING LEAD WAS BEYOND THE EXPECTED UPPER RANGE. BEGINNING 2012 (B)(6), LV PACE LEAD IMPEDANCE MEASURED GREATER THAN 3000 OHMS. ANALYSIS OF THE DEVICE MEMORY INDICATED LEAD IMPEDANCE OUT OF RANGE ALERT. RV (RIGHT VENTRICULAR) LEAD INTEGRITY WARNING OCCURRED 2012 (B)(6) FOR LV RING TO RV COIL IMPEDANCE GREATER THAN 3000 OHMS.

    Additional Manufacturer Narrative · 1

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

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH IMPEDANCE. IT WAS ALSO REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD IMPEDANCE WAS HIGH. LEAD PROGRAMMING WAS ADJUSTED FOR BOTH LEADS, AND THEY REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471321 ATTAIN ABILITY DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 419688

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 6944-65, LEAD