BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 4896449 · Received July 7, 2015

    Report

    Report Number
    3007566237-2015-01892
    Event Type
    Death
    Date Received
    July 7, 2015
    Report Date
    June 15, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID NEU_UNKNOWN_CATH, SERIAL # UNKNOWN, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT READ AN ARTICLE ABOUT THE CONSENT DECREE THAT SAID 14 PEOPLE HAD DIED.

    Description of Event or Problem · 1

    ADDITIONAL REVIEW INDICATED THE PATIENT ACQUIRED THE INFORMATION ABOUT THE 14 DEATHS FROM THE FDA WEBSITE WHEN READING ABOUT RECALLS. AS A RESULT, NO FURTHER INFORMATION WILL BE REPORTED IN THIS MANUFACTURER REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441311 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Death