BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 5028562 · Received August 25, 2015

    Report

    Report Number
    3007566237-2015-02377
    Event Type
    Death
    Date Received
    August 25, 2015
    Report Date
    August 20, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL DEVICES: PRODUCT ID: NEU_UNKNOWN_CATH, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER WHO READ INFORMATION ABOUT THE PUMPS CAUSING DEATHS AND HE WAS CONCERNED BY THAT. NO FURTHER INFORMATION WAS PROVIDED AT THE TIME OF THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561240 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Death