BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY STEERABLE

    MDR report key: 1042022 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34621
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    March 18, 2008
    Report Date
    March 18, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DTB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUITY STEERABLE IMPLANTABLE LEAD DTB CARDIAC PACEMAKERS, INC 4555 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other THE DEVICE 0181/109100 WAS IMPLANTED 18-MAR-2008| THE DEVICE 4537/163174 WAS IMPLANTED 18-MAR-2008| THE DEVICE 0148/102099 WAS IMPLANTED 09-NOV-2000| THE DEVICE 4096/121325 WAS IMPLANTED 03-JUL-2006| THE DEVICE H230/200940 WAS IMPLANTED 03-JUL-2006| THE DEVICE 4554/159860 WAS IMPLANTED 18-MAR-2008