BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN OTW

    MDR report key: 2203382 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11864
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    May 12, 2011
    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
    TX, 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 FOR (B)(4): THE FULL LEAD WAS RETURNED AND ANALYZED. PRIMARY RESULTS REVEALED NO ANOMALIES FOUND. THERE WAS BLOOD/BODY FLUID PRESENT ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT IMPLANT, THE LEAD COULD NOT BE PLACED IN THE TARGET VESSEL. THE LEAD WAS REMOVED AND ANOTHER WAS IMPLANTED. 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 42 YR Other (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIBRILLATOR| 6947 IMPLANTABLE TACHY LEAD| 5976 IMPLANTABLE PACING LEAD