BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN OTW

    MDR report key: 1922766 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-13075
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P010015/S012
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT THE LEFT VENTRICULAR LEAD IS "NOT PROGRAMMED." THE PHYSICIAN'S OFFICE CLARIFIED THAT THE LEAD WAS NO LONGER NEEDED BY PATIENT. THE LEAD REMAINS IN USE BUT IS NOT ACTIVELY PACING. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATTAIN OTW IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4194 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6949 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD