BEUDAMED
    FDA Adverse Event Death Summary report: N

    530G INSULIN PUMP

    MDR report key: 3903575 · Received June 30, 2014

    Report

    Report Number
    3004209178-2014-86337
    Event Type
    Death
    Date Received
    June 30, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 29, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    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

    A COMPANY REPRESENTATIVE CALLED TO REPORT THAT SHE RECEIVED AN EMAIL REGARDING THE SUDDEN DEATH OF THE PATIENT. SHE STATED THAT THE PATIENT PASSED AWAY DUE TO SEPSIS. THE DATE OF DEATH WAS NOT KNOWN, BUT IT WAS STATED THAT THE PATIENT'S DEATH OCCURRED WITHIN THE PAST FEW DAYS. MULTIPLE PHONE CALLS WERE MADE TO THE NUMBERS ON FILE, BUT THERE WAS NO ANSWER. NO FURTHER INFORMATION REGARDING THE PATIENT'S DEATH WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379749 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Death