BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PUMP

    MDR report key: 2032503 · Received March 24, 2011

    Report

    Report Number
    3007566237-2011-02264
    Event Type
    Injury
    Date Received
    March 24, 2011
    Date of Event
    March 6, 2011
    Report Date
    March 6, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN CALLED AND STATED A PT WAS FOUND UNCONSCIOUS. THE PHYSICIAN DIDN'T KNOW THE PT'S NAME, BUT THE PHYSICIAN THOUGHT THAT HE HAD A PUMP. IT WAS THOUGHT THAT THE PUMP DELIVERED MORPHINE SULFATE. THE PHYSICIAN STATED THAT HE WOULD CALL BACK LATER WITH THE PT INFO. SEVERAL ATTEMPTS WERE MADE TO RE-CONTACT THE REPORTING PHYSICIAN WITH THE CONTACT INFO PROVIDED AT THE TIME OF THE INITIAL CALL; THE ATTEMPTS WERE UNSUCCESSFUL. FURTHER FOLLOW UP IS NOT POSSIBLE AT THIS TIME DUE TO LACK OF ADD'L CONTACT INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN PUMP LKK MEDTRONIC NEUROMODULATION PUMP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other