BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2063761 · Received April 14, 2011

    Report

    Report Number
    3007566237-2011-02812
    Event Type
    Injury
    Date Received
    April 14, 2011
    Report Date
    March 30, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE HAS BEEN RETURNED TO THE MFR FOR ANALYSIS. A F/U REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF THE DEVICE CONCLUDED NORMAL DEVICE FUNCTION. (B)(4). MEDTRONIC

    Description of Event or Problem · 1

    THE PT FELT THAT THE PUMP WAS RUNNING FASTER THAN NORMAL; THE PUMP HAD LESS DRUG THAN EXPECTED FOR THE LAST COUPLE OF REFILLS. AT REPLACEMENT, THE PUMP STATED 28.9 ML LEFT; ONLY 19 ML WAS ACTUALLY IN THE PUMP. THE PT COULD TELL THE DIFFERENCE BETWEEN THE OLD AND NEW PUMP FUNCTION. THERE WAS REPORTED TO BE NO PT INJURY. THE DEVICE SYSTEM WAS USED TO DELIVER COMPOUNDED MORPHINE (25 MG/ML) AND BACLOFEN (150 MCG/ML).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention IMPLANTED:| CATHETER: MODEL 8578, LOT# N280913015| EXPLANTED:| IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709, LOT# N12396R27