BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED

    MDR report key: 254885 · Received December 13, 1999

    Report

    Report Number
    6000030-1999-00275
    Event Type
    Malfunction
    Date Received
    December 13, 1999
    Date of Event
    October 13, 1999
    Report Date
    November 8, 1999
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LKK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    HCP REPORTED THAT PT STARTED TO REQUIRE MORE FREQUENT ADJUSTMENTS OF DOSE ETC TO HER INTRATHECAL PUMP IN JANUARY 1999. SHE BEGAN TO REQUIRE ORAL MEDICATIONS TO SUPPLEMENT HER INTRATHECAL MEDICATIONS IN ORDER TO ACHIEVE PAIN RELIEF IN ADDITION TO THE DOSE AND CONCENTRATION INCREASES. ON 08/25/1999 THE PUMP WAS FOUND TO HAVE DISPENSED ONLY 2 ML OF MEDICATION. THE ROTOR OF THE PUMP WAS TESTED AND FOUND TO BE STALLED. PUMP WAS SUCCESSFULLY REPLACED IN 1999.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED Implant IMPLANTABLE INFUSION PUMP LKK MEDTRONIC, INC. 861718 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization SPINAL CATHETER MODEL8703W LOT #44337 IMPLANTED| 1997 STATUS UNK.