BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2922633 · Received January 18, 2013

    Report

    Report Number
    3004209178-2013-00763
    Event Type
    Injury
    Date Received
    January 18, 2013
    Report Date
    December 28, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 8709SC LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE CATHETER PRODUCT ID, 8 596SC LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM ON THE DATE OF REPORT OR THE DATE PRIOR WITH HEADACHE AND FEVERS WHICH "LOOKED LIKE" SPINAL MENINGITIS OR PNEUMONIA. LATER THAT DAY, THE PATIENT WAS BEING WORKED UP FOR QUESTIONABLE MENINGITIS. IT APPEARED THE PHYSICIAN WAS RULING IT OUT WITH A SPINAL TAP AND LOOKING INTO OTHER CAUSES. THE PATIENT WAS STARTED ON ANTIBIOTICS AND WAS RESPONDING. AT THE TIME OF REPORT THE PHYSICIAN WAS NOT CHANGING ANYTHING WITH THE PUMP OR EXPLANTING IT. IT WAS ALSO NOTED THE PATIENT HAD AN MRI. THE DEVICE SYSTEM WAS USED TO DELIVER DILAUDID, CLONIDINE, AND BUPIVACAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27444 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention