BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 3863419 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-06740
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    January 10, 2012
    Report Date
    April 2, 2012
    Manufacturer
    MPRI
    Product Code
    LWP
    PMA / PMN Number
    P010015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IT WAS IMPOSSIBLE TO CAPTURE THE LEFT VENTRICULAR (LV) LEAD AT HIGHER OUTPUTS AND THE LEAD WAS REPORTED TO HAVE DISLODGED. THE LEAD WAS INACTIVATED AND REMAINS IN THE PATIENT. THE PATIENT WAS ENROLLED IN (B)(4). NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341171 ATTAIN OTW PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MPRI 419478

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Required Intervention