BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY PLUS

    MDR report key: 2951951 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00301
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    October 13, 2012
    Report Date
    November 8, 2012
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY #THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. THERE WERE NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM AND WAS DIAGNOSED WITH PHRENIC NERVE STIMULATION. AN X-RAY CONFIRMED THE NERVE STIMULATION ON THE LEFT VENTRICULAR (LV) LEAD. THE LV LEAD WAS INACTIVATED AND THE PATIENT WAS WAITING A LEAD REPOSITIONING. THE PATIENT WAS A PARTICIPANT IN THE MONITORING RESYNCHRONIZATION DEVICES AND CARDIAC PATIENTS ((B)(6)), BUT WAS WITHDRAWN FROM THE STUDY UNTIL THE LEAD REPOSITIONING TAKES PLACE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56773 ATTAIN ABILITY PLUS DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 429688

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Hospitalization| R (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (IC