BEUDAMED
    FDA Adverse Event Death Summary report: N

    SECURA DR

    MDR report key: 2083048 · Received May 10, 2011

    Report

    Report Number
    2647346-2011-00664
    Event Type
    Death
    Date Received
    May 10, 2011
    Date of Event
    September 15, 2009
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S114
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DIED APPROXIMATELY FOUR MONTHS AFTER DEVICE IMPLANT. THE RELATEDNESS OF THE DEATH TO THE DEVICE IS REPORTED AS UNKNOWN. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEVIED. FOLLOW UP REVEALED THE PATIENT WAS NOT PACEMAKER DEPENDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SECURA DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D224DRG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death