BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY

    MDR report key: 3863415 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-06739
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    January 10, 2012
    Report Date
    April 10, 2012
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LOSS OF CAPTURE WAS OBSERVED ON THE LEFT VENTRICULAR (LV) LEAD. THRESHOLD RISE HAD BEEN NOTED RIGHT AFTER IMPLANT. REPROGRAMMING THE LV CHANNEL OUTPUT TO A HIGHER SETTING WAS ATTEMPTED WITH NO SUCCESS AS THE PACING THRESHOLD WAS TOO HIGH. THE LEAD REMAINS IMPLANTED BUT IS NOT FUNCTIONAL. THE PATIENT HAD ANOTHER LV CONNECTED WITH A Y-ADAPTOR AND THIS LEAD WAS USED FOR PACING. THE PATIENT IS ENROLLED IN THE(B)(6) CLINICAL STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339116 ATTAIN ABILITY DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 419688

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Required Intervention