BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 3210145 · Received July 8, 2013

    Report

    Report Number
    3007566237-2013-02273
    Event Type
    Death
    Date Received
    July 8, 2013
    Report Date
    June 14, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE DATE OF DEATH IS UNKNOWN, THE DATE PROVIDED IS THE DATE OF NOTIFICATION OF THE PATIENT¿S DEATH.

    Description of Event or Problem · 1

    THE REPORTER WAS INFORMED OF A PATIENT'S DEATH AND IT WAS STATED "A DOCTOR DID A PUMP TRIAL AND THEIR PATIENT DIED FROM IT". REPORTER HAD NO FURTHER INFORMATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT WHEN IT BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION OBTAINED LATER INDICATED THAT THE EVENT HAD OCCURRED 5-6 YEARS AGO AND IT DID NOT INVOLVE MANUFACTURE DEVICE/ COMPONENTS. IT WAS STATED THAT DURING A SPINAL TAP INTRATHECAL, MORPHINE WAS GIVEN TO TEST OUT POSSIBLE DOSING AND THE PATIENT ARRESTED. AUTOPSY RESULTS LATER SHOWED THAT THE PATIENT HAD HIGH LEVELS OF OXYCONTIN IN HIS BLOOD STREAM EVEN THOUGH HE WAS ADVISED NOT TO TAKE ANY PAIN MEDICATIONS FOR A FEW WEEKS PRIOR TO THE TRIAL. PATIENT SUFFERED HEART ATTACK DUE TO OVERDOSE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: REPORTER BELIEVED THAT THE PATIENT MAY HAVE BEEN TRIALED WITH A NARCOTIC BUT WAS NOT SURE. REPORTER HAD NO FURTHER INFORMATION REGARDING PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309875 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death