BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN OTW

    MDR report key: 2050837 · Received April 12, 2011

    Report

    Report Number
    2649622-2011-05439
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    January 24, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P010015/S003
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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. EVALUATION SUMMARY: (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. LOW RESISTANCE/IMPEDANCE WAS OBSERVED. THE DAILY PACE IMPEDANCE TREND DATA SHOWS A DECREASE FOR LV PACE FROM 544 TO 200 OHMS MINIMUM BETWEEN (B)(4)-2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A RIGHT VENTRICULAR LEAD REVISION, AND AFTER THE REVISION, THE LEFT VENTRICULAR LEAD IMPEDENCE DROPPED TO UNDER TWO HUNDRED OHMS. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS WERE 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. 4193 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other 6947 IMPLANTABLE TACHY LEAD| 6940 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB