BEUDAMED
    FDA Adverse Event Death Summary report: N

    ATTAIN OTW

    MDR report key: 1893481 · Received November 8, 2010

    Report

    Report Number
    2649622-2010-12052
    Event Type
    Death
    Date Received
    November 8, 2010
    Date of Event
    April 13, 2010
    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: (B)(4) FULL LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES FOUND.

    Additional Manufacturer Narrative · 1

    ASKU

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DIED APPROXIMATELY FOUR MONTHS AFTER AN IMPLANT ATTEMPT OF THE LEAD. ANOTHER LEAD WAS IMPLANTED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    THE LEAD WAS ATTEMPTED BUT NOT IMPLANTED DUE TO PATIENT ANATOMY. ANOTHER LEAD WAS IMPLANTED. AN AV JUNCTION ABLATION WAS PERFORMED AT THIS PROCEDURE. IT WAS DETERMINED THE PATIENT HAD EXPIRED. FOLLOW UP WITH THE CLINIC REPORTED THE CAUSE OF DEATH WAS ACUTE GI HEMORRHAGE, NON INFECTION AND THE DEATH WAS NOT DEVICE RELATED. PATIENT WAS LAST SEEN BY HCP ON (B)(6) 2010 AND "EVERYTHING WAS FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATTAIN OTW ASKU DTB MEDTRONIC PUERTO RICO, INC. 4194 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death| H| R