BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN

    MDR report key: 2955206 · Received February 11, 2013

    Report

    Report Number
    2182208-2013-00260
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    November 1, 2012
    Report Date
    December 10, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    DTB
    PMA / PMN Number
    P010015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. REFERENCED ARTICLE: "CARDIAC VENOUS LEFT VENTRICULAR LEAD REMOVAL AND REIMPLANTATION FOLLOWING DEVICE INFECTION: A LARGE SINGLE-CENTER EXPERIENCE. JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY." (B)(6) 2012;23(11):1213-1216.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING THIS LEAD MODEL. ONE PATIENT WAS REPORTED TO HAVE THE LEAD EXTRACTED DUE TO DEVICE INFECTION. THE LEAD APPEARS TO HAVE BEEN SUCCESSFULLY REMOVED AND REPLACED. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59740 ATTAIN ELECTRODE, PACEMAKER, PERMANENT DTB RICE CREEK MFG 4189

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R