BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY

    MDR report key: 4160562 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-11857
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 9, 2014
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 PRODUCTS: 6935M62 LEAD, IMPLANTED: (B)(6) 2014; A 407652 LEAD, IMPLANTED: (B)(6) 2014. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD¿S THRESHOLD HAD INCREASED. IT WAS NOTED THAT THE POSITION OF THE LEAD ON FLUORO LOOKED THE SAME. THE LV LEAD WAS REMOVED. ADDITIONALLY, THE RIGHT VENTRICULAR (RV) LEAD HAD INCREASED THRESHOLDS AND THE R-WAVE SENSING HAD DECREASED. THE RV LEAD WAS REPOSITIONED AND 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
    641104 ATTAIN ABILITY DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 419688

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Hospitalization| R DTBA1D4