BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY PLUS

    MDR report key: 3992063 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-10059
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    April 16, 2014
    Report Date
    June 10, 2014
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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: 6947M62 LEAD IMPLANTED: (B)(6) 2012; 407652 LEAD IMPLANTED: (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH EXTRACARDIAC STIMULATION. THE PATIENT WAS NOTED TO HAVE PHRENIC NERVE STIMULATION CA USED BY THE LEFT VENTRICULAR (LV) LEAD WHEN THE PATIENT LIES ON THEIR LEFT SIDE. THE PHYSICIAN WAS UNABLE TO REPRODUCE THE STIMULATION IN THE LV VECTOR. THE LV LEAD POLARITY WAS REPROGRAMMED AND THE LV LEAD REMAINS IN USE. THE PATIENT IS A PARTICIPANT IN THE (B)(6) STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470964 ATTAIN ABILITY PLUS DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 429678

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Required Intervention D204TRM CRT-D