BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN OTW

    MDR report key: 2811416 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-17105
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    September 28, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P010015/S003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY (B)(4): THE FULL LEAD WAS RETURNED TO THE MANUFACTURER AND ANALYZED AND NO ANOMALIES WERE FOUND. THERE WAS BLOOD ON THE ELECTRODE - TIP ELECTRODE AND THE DISTAL CONDUCTOR HAD BLOOD/BODY FLUID (NOT OBSTRUCTED.)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE OF THE LEFT VENTRICULAR (LV) LEAD WHEN THE LV LEAD REACHED THE LEFT VEIN THE THRESHOLD WAS TOO HIGH AND THE PATIENT FELT UNCOMFORTABLE. THEREFORE, THE LV LEAD WAS REMOVED AND REPLACED WITH A NEW LEAD. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other