BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1230568 · Received November 13, 2008

    Report

    Report Number
    3004209178-2008-07462
    Event Type
    Injury
    Date Received
    November 13, 2008
    Date of Event
    August 6, 2008
    Report Date
    October 16, 2008
    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
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    RESULTS: USED FOR THE CATHETER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS HAVING CLEAR FLUID DRAINAGE FROM THE LUMBAR INCISION SITE. THERE WAS DEHISCENCE AT THE LUMBAR WOUND CATHETER SITE. THERE WERE NO SIGNS OF INFECTION; THE FLUID WAS SUGGESTIVE OF AN INTRATHECAL FLUID LEAK. THE PT WAS TAKEN TO SURGERY WHERE THE PROXIMAL END OF THE CATHETER WAS SPLICED. THE DISTAL END OF THE CATHETER WAS REPLACED AND CONNECTED TO THE OLD CATHETER USING A CATHETER CONNECTION DEVICE. THE PUMP CONTAINED MORPHINE SULFATE 2.5 MG/ML AT A DAILY DOSE OF 1.2 MG IN SIMPLE CONTINUOUS MODE. THE PT RECOVERED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Required Intervention EXPLANTED:| PROGRAMMER: MODEL 8840| CATHETER: MODEL 8709