BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY

    MDR report key: 3151809 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-05617
    Event Type
    Injury
    Date Received
    June 7, 2013
    Report Date
    September 16, 2013
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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: 4076, IMPLANTABLE PACING LEAD, (B)(6) 2010; 4076, IMPLANTABLE PACING LEAD, (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PHRENIC NERVE STIMULATION. THE LEFT VENTRICULAR (LV) LEAD WAS REPROGRAMMED AND REMAINS IN USE. THE PATIENT IS A PARTICIPANT IN THE SYSTEM LONGEVITY STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PHRENIC NERVE STIMULATION. THE LEFT VENTRICULAR (LV) LEAD WAS REPROGRAMMED AND RE MAINS IN USE. THE PATIENT IS A PARTICIPANT IN THE (B)(6) STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PATIENT CONTINUED TO HAVE POSITIONAL EXTRACARDIAC STIMULATION AND FURTHER REPROGRAMMING WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252428 ATTAIN ABILITY DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 419688

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Required Intervention (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (I