BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY

    MDR report key: 3152976 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-05772
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    March 3, 2013
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    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 PRODUCTS: D224TRK, IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), (B)(6) 2010; 1688TC, IMPLANTABLE PACING LEAD, (B)(6) 2010; 6947, IMPLANTABLE TACHY LEAD, (B)(6) 2010. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR LEAD OUTPUTS HAD TO BE INCREASED DUE TO INCREASED PACING THRESHOLDS AND RISING AND HIGH IMPEDANCES. THE LEAD REMAINS 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
    254712 ATTAIN ABILITY DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 419688

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR Required Intervention