BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY OTW

    MDR report key: 3151819 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-05610
    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. 6935 IMPLANTABLE TACHY LEAD 2010 (B)(6); 4076 IMPLANTABLE PACING LEAD 2010 (B)(6). (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.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT HAD BEGUN EXPERIENCING PHRENIC NERVE STIMULATION AGAIN. THE LEFT VENTRICULAR (LV) LEAD WAS REPROGRAMMED 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
    252693 ATTAIN ABILITY OTW DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 419678

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Required Intervention (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (I