BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN OTW

    MDR report key: 1875013 · Received October 19, 2010

    Report

    Report Number
    2649622-2010-11613
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    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
    KS, US
    Reporter Occupation
    PHYSICIAN

    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 FULL LEAD WAS RETURNED IN SEGMENTS AND ANALYZED WITH NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ATRIAL LEAD PACING THRESHOLD WAS HIGH, RIGHT VENTRICULAR LEAD IS AT HIGH RISK OF FRACTURE, LEFT VENTRICULAR LEAD HAD NOT OPTIMALLY WORKED IN THE PAST (DIAPHRAGMATIC STIMULATION) AND THE DEVICE IS CLOSE TO BATTERY DEPLETION. THE DEVICE, ATRIAL AND RIGHT VENTRICULAR LEAD WERE EXPLANTED AND REPLACED. THE LV LEAD REMAINS IN USE. 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. 4193 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention 7303 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6949 IMPLANTABLE TACHY LEAD