BEUDAMED
    FDA Adverse Event Death Summary report: N

    ATTAIN OTW

    MDR report key: 1964496 · Received January 20, 2011

    Report

    Report Number
    2649622-2011-00079
    Event Type
    Death
    Date Received
    January 20, 2011
    Date of Event
    October 5, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P010015/S003
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS INFORMATION WAS RECEIVED FROM A COMPETITOR. ALL DATA PERTINENT TO THE EVENT IS PROVIDED. EVALUATION SUMMARY (B)(4) DISTAL CONDUCTOR FRACTURED AND DISTORTED AND BLOOD/BODY FLUID (NOT OBSTRUCTED), OUTER INSULATION SEPARATION AND BREACHED CUT AND COSMETIC DEPRESSION. PARTIAL LEAD IN SEGMENTS RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    THE LEAD WAS RETURNED TO THE MANUFACTURER FOLLOWING THE PATIENT'S DEATH, ANALYZED, AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATTAIN OTW IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4193 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death 5076 IMPLANTABLE PACING LEAD| 7299 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6949 IMPLANTABLE TACHY LEAD