BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 2123425 · Received June 14, 2011

    Report

    Report Number
    2649622-2011-08122
    Event Type
    Injury
    Date Received
    June 14, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P010015/S012
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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): NO ANOMALIES FOUND. FULL LEAD RETURNED AND ANALYZED. ADDITIONAL FINDING OF ALL CONDUCTORS BLOOD/BODY FLUID (NOT OBSTRUCTED).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR LEAD EXHIBITED HIGH THRESHOLDS. DURING THE REPLACEMENT PROCEDURE, A SECOND LEFT VENTRICULAR LEAD IMPLANTATION WAS ATTEMPTED, BUT NOT SUCCESSFUL BECAUSE THE LEAD COULD NOT ACHIEVE ADEQUATE PLACEMENT. THE LEAD WAS REMOVED AND NOT REPLACED. THE CHRONIC LEFT VENTRICULAR LEAD IS STILL IN USE. NO PATIENT COMPLICATIONS WERE 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 45 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE TACHY LEAD