BEUDAMED
    FDA Adverse Event Death Summary report: N

    MODEL NOT SPECIFIED

    MDR report key: 3903531 · Received June 30, 2014

    Report

    Report Number
    3004209178-2014-86357
    Event Type
    Death
    Date Received
    June 30, 2014
    Date of Event
    December 23, 2013
    Report Date
    January 2, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA E-MAIL THAT THE CUSTOMER PASSED AWAY. ATTEMPTED TO CONTACT THE CALLER TO GATHER MORE INFORMATION REGARDING THE CUSTOMER'S DEATH WITH NO RESULTS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379691 MODEL NOT SPECIFIED OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death