BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY

    MDR report key: 3860651 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-05344
    Event Type
    Injury
    Date Received
    June 10, 2014
    Report Date
    March 7, 2014
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: D314TRG, BI-VENTRICULAR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, (B)(6) 2012. A 5076, IMPLANTABLE PACING LEAD: (B)(6) 2007. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD FAILED TO CAPTURE AT MAXIMUM OUTPUT AND HAD HIGH THRESHOLDS. THE LV LEAD WAS CAPPED AND REPLACED. THE DEVICE HAD UNEXPECTED LONGEVITY AND WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339639 ATTAIN ABILITY DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 419688

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Hospitalization| R 6935, IMPLANTABLE TACHY LEAD