BEUDAMED
    FDA Adverse Event Death Summary report: N

    ATTAIN OTW

    MDR report key: 2001203 · Received February 24, 2011

    Report

    Report Number
    2649622-2011-03089
    Event Type
    Death
    Date Received
    February 24, 2011
    Date of Event
    April 9, 2003
    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
    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.

    Additional Manufacturer Narrative · 1

    ASKU

    Description of Event or Problem · 1

    IT WAS NOTED THE PATIENT DIED APPROXIMATELY TWO MONTHS FOLLOWING DEVICE IMPLANT. THE CAUSE OF DEATH IS BEING REQUESTED.

    Description of Event or Problem · 1

    IT WAS NOTED THE PATIENT DIED APPROXIMATELY TWO MONTHS FOLLOWING DEVICE IMPLANT. FOLLOW UP WITH THE CLINIC REPORTED THEY DO NOT HAVE THE CAUSE OF DEATH, HOWEVER, THERE IS NO INDICATION OF ANY DEVICE OR LEAD ISSUES AROUND THE TIME OF DEATH. THEIR RECORDS DO INDICATED THAT THE PATIENT DID HAVE A HISTORY OF SEVERE HEART FAILURE.

    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 62 YR Death