BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY STEERABLE

    MDR report key: 1254153 · Received November 11, 2008

    Report

    Report Number
    2124215-2008-40717
    Event Type
    Malfunction
    Date Received
    November 11, 2008
    Date of Event
    September 18, 2008
    Report Date
    September 18, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWP
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUITY STEERABLE IMPLANTABLE LEAD LWP CARDIAC PACEMAKERS, INC 4554 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Other THE DEVICE 0184/152052 WAS IMPLANTED 18-SEP-2008| THE DEVICE 1190/164408 WAS IMPLANTED 18-FEB-2008| THE DEVICE 4086/233922 WAS IMPLANTED 18-FEB-2008| THE DEVICE 4554/ WAS IMPLANTED| THE DEVICE N119/009308 WAS IMPLANTED 18-SEP-2008