BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 3151992 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-05572
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    August 25, 2011
    Report Date
    March 14, 2013
    Manufacturer
    MPRI
    Product Code
    LWP
    PMA / PMN Number
    P010015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. CONCOMITANT PRODUCTS: 6947 IMPLANTABLE TACHY LEAD -(B)(6) 2011; 4076 IMPLANTABLE PACING LEAD - (B)(6) 2011. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WITHIN A COUPLE OF DAYS OF IMPLANT, THE LEFT VENTRICULAR (LV) LEAD WAS FOUND TO HAVE DISLODGED. THE LEAD WAS REPOSITIONED, AND REMAINS IN USE. THE PATIENT IS ENROLLED IN THE SYSTEM LONGEVITY STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253324 ATTAIN OTW PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MPRI 419478

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Hospitalization| R D224TRK IMPLANTABLE DEFIBRILLATOR