BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4220731 · Received November 3, 2014

    Report

    Report Number
    3004209178-2014-20835
    Event Type
    Injury
    Date Received
    November 3, 2014
    Report Date
    October 9, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: 2014 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT FELT THEIR DOSING WAS TOO HIGH. THEY WERE VERY SLUGGISH. THE PUMP CONTAINED BACLOFEN. PATIENT SYMPTOMS, INTERVENTIONS, AND OUTCOME WERE REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701240 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Other