BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY OTW

    MDR report key: 3151802 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-05618
    Event Type
    Injury
    Date Received
    June 7, 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
    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. PRODUCTS: 6947 IMPLANTABLE TACHY LEAD, (B)(6) 2008; 4076 IMPLANTABLE PACING LEAD, (B)(6) 2008. (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 RE MAINS 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253216 ATTAIN ABILITY OTW DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 419678

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Required Intervention D314TRG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (I