BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 3151731 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-05645
    Event Type
    Injury
    Date Received
    June 7, 2013
    Report Date
    March 4, 2013
    Manufacturer
    MPRI
    Product Code
    LWP
    PMA / PMN Number
    P010015
    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. A 6949 IMPLANTABLE TACHY LEAD, (B)(6) 2007. A 4076 IMPLANTABLE PACING LEAD, (B)(6) 2007. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD WAS EXHIBITING UNSTABLE THRESHOLDS AS WELL AS LOSS OF CAPTURE, AT WHICH POINT THE ATRIUM WAS CAPTURED WHEN PACING ON THE LV LEAD. THE 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
    253183 ATTAIN OTW PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MPRI 419388

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Hospitalization| R D224TRK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR