BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722NAP PRDGM INS V2.2 PL EN

    MDR report key: 1882576 · Received October 22, 2010

    Report

    Report Number
    3004209178-2010-83186
    Event Type
    Injury
    Date Received
    October 22, 2010
    Date of Event
    October 12, 2010
    Report Date
    October 12, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS INVOLVED IN A CAR ACCIDENT AND WAS HOSPITALIZED. THE MOTHER STATED THAT THE ACCIDENT WAS SEVERE AND THE AIRBAG DEPLOYED ON THE INSULIN PUMP. ADVISED THE MOTHER THAT THE CUSTOMER SHOULD DISCONTINUE USE OF THE INSULIN PUMP UNTIL A REPLACEMENT OF THE DEVICE ARRIVES. NO FURTHER INFORMATION WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722NAP PRDGM INS V2.2 PL EN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization