BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2599778 · Received June 5, 2012

    Report

    Report Number
    3004209178-2012-04037
    Event Type
    Malfunction
    Date Received
    June 5, 2012
    Report Date
    May 8, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    IMPLANTED: (B)(6) 2009, EXPLANTED: PRODUCT TYP CATHETER PRODUCT ID 8590-1, LOT# N171755, SERIAL# IMPLANTED: (B)(6) 2009, EXPLANTED: PRODUCT TYP ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT WAS NOT RESPONDING TO DOSE INCREASES. IT WAS NOT POSSIBLE TO ASPIRATE VIA THE CATHETER ACCESS PORT; A CATHETER ISSUE WAS SUSPECTED. THE PUMP CONTAINED BACLOFEN. ADDITIONAL INFORMATION IS BEING REQUESTED AT THIS TIME; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 PRODUCT ID 8709SC LOT# SERIAL# (B)(4)