BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN INFUSION PUMP

    MDR report key: 4110397 · Received September 23, 2014

    Report

    Report Number
    3007566237-2014-02666
    Event Type
    Injury
    Date Received
    September 23, 2014
    Report Date
    August 26, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHARMACY EMPLOYEE STOLE MORPHINE AND REPLACED THE DRUG WITH METHADONE. SEVENTEEN PATIENTS WERE AFFECTED BY THIS AND EVERYONE WAS REPORTEDLY PARALYZED. NO INTERVENTIONS, OUTCOME, OR PATIENT IDENTIFIERS WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592327 UNKNOWN INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability