BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN OTW

    MDR report key: 1855233 · Received October 6, 2010

    Report

    Report Number
    2649622-2010-09677
    Event Type
    Malfunction
    Date Received
    October 6, 2010
    Date of Event
    August 20, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P010015/S012
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 AND ANALYZED. ANALYSIS RESULTS REVEALED NO ANOMALIES WERE FOUND. BLOOD/BODY FLUID WAS PRESENT ON THE DISTAL CONDUCTOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LEFT VENTRICULAR PACING LEAD WAS NOT IMPLANTED DUE TO THE PATIENT'S VEIN BEING TOO SMALL TO ADVANCE THE LEAD; THE LEAD WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO 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 43 YR Required Intervention