BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN OTW

    MDR report key: 1926079 · Received December 14, 2010

    Report

    Report Number
    2649622-2010-14159
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    September 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
    CT, 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): NO ANOMALIES WERE FOUND; THE FULL LEAD WAS RETURNED AND ANALYZED. BLOOD/BODY FLUID WAS NOTED ON THE DISTAL CONDUCTOR(NOT OBSTRUCTED).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DUE TO THE PATIENT'S ANATOMY THE LEFT VENTRICULAR LEAD COULD NOT BE PLACED DURING THE IMPLANT PROCEDURE. THE LEAD WAS REMOVED AND NOT REPLACED AT THAT TIME. THE PATIENT WAS SCHEDULED TO HAVE AN EPICARDIAL LEAD PLACED AT A LATER DATE. 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 56 YR Other