BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3831249 · Received May 23, 2014

    Report

    Report Number
    3004209178-2014-84981
    Event Type
    Death
    Date Received
    May 23, 2014
    Date of Event
    April 17, 2014
    Report Date
    May 8, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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 THAT THE CUSTOMER PASSED AWAY. THE HUSBAND STATED THAT THE CUSTOMER WAS IN A COMA FROM (B)(6) 2014. IT WAS STATED THAT THE CAUSE OF THE DEATH WAS AN OPEN HEART SURGERY AND AN INFECTION. THE CALLER ALSO STATED THAT THEY WENT TO A VACATION ON (B)(6) 2014 AND THE CUSTOMER WAS WEARING THE PUMP. HUSBAND STATED THAT THE CUSTOMER WAS HAVING PROBLEMS WITH THE INSULIN PUMP AND THE CANNULA BENDING. HUSBAND WAS NOT SURE WHEN THE CUSTOMER DISCONNECTED THE INSULIN PUMP. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308505 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death