BEUDAMED
    FDA Adverse Event Death Summary report: N

    SECURA DR

    MDR report key: 2834225 · Received November 15, 2012

    Report

    Report Number
    3004209178-2012-10329
    Event Type
    Death
    Date Received
    November 15, 2012
    Date of Event
    October 5, 2012
    Report Date
    October 25, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S114
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. PRODUCT EVENT SUMMARY: (B)(4) THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. FOR USE BY USER FACILITY/IMPORTER(DEVICES ONLY). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S FAMILY MEMBER THAT THE PATIENT IS DECEASED AND THE FAMILY MEMBER ALLEGES THE DEVICE SYSTEM CONTRIBUTED TO THE PATIENT'S DEATH. ATTEMPTS TO OBTAIN CAUSE OF DEATH INFORMATION WERE UNSUCCESSFUL. THE PATIENT WAS FOUND DECEASED AT HOME BY THE FAMILY. NO ALLEGATION OF DEVICE RELATEDNESS WAS RECEIVED FROM THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SECURA DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC PUERTO RICO OPERATIONS CO. D224DRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Death 5076 IMPLANTABLE PACING LEAD