BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHROMED II

    MDR report key: 2970448 · Received February 20, 2013

    Report

    Report Number
    3004209178-2013-02922
    Event Type
    Death
    Date Received
    February 20, 2013
    Date of Event
    January 21, 2013
    Report Date
    January 28, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD "PASSED AWAY FROM THE MEDTRONIC PAIN PUMP." THE REPORTER EXPRESSED DISSATISFACTION WITH THE PRIMARY PHYSICIAN. IN ADDITION, THE PATIENT HAD NOT WORKED WITH THE PHYSICIAN AT ALL. THE DRUG USED IN THIS SYSTEM WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74284 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Death