BEUDAMED
    FDA Adverse Event Death Summary report: N

    ATTAIN OTW

    MDR report key: 2250308 · Received September 15, 2011

    Report

    Report Number
    2649622-2011-13869
    Event Type
    Death
    Date Received
    September 15, 2011
    Date of Event
    May 27, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P010015/S003
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S SPOUSE THAT THE PATIENT IS DECEASED. IT WAS FURTHER REPORTED BY THE FAMILY THAT THE PATIENT FELL OFF THE BED AND THE DEVICE DID NOT GO OFF. ADDITIONAL INFORMATION OBTAINED INDICATED THE CAUSE OF DEATH WAS ASYSTOLE AND THE PATIENT DIED AT HOME. NO INFORMATION REGARDING CIRCUMSTANCES OF DEATH IS AVAILABLE.

    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 74 YR Death