BEUDAMED
    FDA Adverse Event Death Summary report: N

    ATTAIN OTW

    MDR report key: 2021121 · Received March 16, 2011

    Report

    Report Number
    2649622-2011-04030
    Event Type
    Death
    Date Received
    March 16, 2011
    Date of Event
    June 18, 2007
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P010015/S003
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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. ALL INFORMATION KNOWN WAS PROVIDED PER THE COMPLAINANT. THEREFORE, NO ATTEMPTS FOR ADDITIONAL INFORMATION WILL BE MADE. THE LEAD MODEL 6949 IS PART OF THE ADVISORY FOR THE MODEL.

    Description of Event or Problem · 1

    AN ALLEGATION FROM AN ATTORNEY INDICATED THE PATIENT DIED APPROXIMATELY NINETEEN MONTHS POST IMPLANT OF THE RIGHT VENTRICULAR LEAD. IT WAS ALSO NOTED THE PATIENT SUFFERED SEVERE PHYSICAL INJURY. FURTHER REVIEW OF THE EVENT REVEALED THE PATIENT DIED APPROXIMATELY FIVE MONTHS POST IMPLANT OF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR AND LEADS.

    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 26 YR Death