BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_INFUSION_PUMP

    MDR report key: 5808763 · Received July 20, 2016

    Report

    Report Number
    3007566237-2016-02691
    Event Type
    Injury
    Date Received
    July 20, 2016
    Report Date
    July 20, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ON 2016-06-28, INFORMATION WAS RECEIVED FROM AN ATTORNEY REGARDING A PATIENT WHO WAS ALLEGED TO HAVE BEEN INJURED DUE TO THE DEVICE SYSTEM'S FAILURE TO DELIVER MEDICATIONS AS PRESCRIBED, WHICH REQUIRED REMOVAL OF THE DEFECTIVE DEVICE; THE NATURE OF THE PERSONAL INJURIES WAS NOT SPECIFIED. INDICATIONS FOR PUMP USE, MEDICAL HISTORY, AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE UNSPECIFIED INJURIES WERE REPORTED TO HAVE OCCURRED "WITHIN THE PAST SEVERAL YEARS"; AS OF THE LETTER DATED 2016-06-21, WHICH WAS RECEIVED BY THE MANUFACTURER ON 2016-06-28. IT WAS REPORTED THAT WRONGFUL DEATH RESULTED IN "SOME INSTANCES," BUT IT WAS NOT SPECIFIED IF THE PATIENT IN THIS EVENT ACTUALLY DIED. THE REPORTEDLY DEFECTIVE DEVICE SYSTEM CAUSED THE PATIENT AND THEIR FAMILY PERSONAL AND ECONOMIC INJURIES INCLUDING BUT NOT LIMITED TO INJURIES AND MEDICAL BILLS RELATED TO THE FAILURE OF THE DEVICE,AND INJURIES AND MEDICAL BILLS CAUSED BY THE SURGERY OR SURGERIES TO REMOVE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463347 UNKNOWN_INFUSION_PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention