BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3093010 · Received May 3, 2013

    Report

    Report Number
    3004209178-2013-07310
    Event Type
    Injury
    Date Received
    May 3, 2013
    Report Date
    April 4, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HCP SAW THE PATIENT IN HIS OFFICE ON (B)(6) 2013. THE PUMP POCKET SITE WAS REDDENED, SWOLLEN, AND WARM TO TOUCH. THE PATIENT HAD RECENTLY HAD A WOUND DEBRIDED THAT WAS DIRECTLY NEXT TO THE PUMP SITE. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND SEEN BY THE NEUROSURGEON. THE PATIENT HAD AN EXPLANT OF THE PUMP AND CATHETER ON (B)(6) 2013. A CULTURE WAS TAKEN FROM THE DEVICE POCKET AND BLOOD. THE POCKET WAS CULTURED AND FOUND TO BE (B)(6). ANTIBIOTIC TREATMENT WAS NECESSARY. THE PATIENT WAS IN ICU INTUBATED WITH RESPIRATORY ISSUES. THIS WAS NOT RELATED TO THE EXPLANTATION OF PUMP BUT DUE TO PNEUMONIA. THE PATIENT WAS STARTED ON ORAL BACLOFEN 20 MG QID, VALIUM 5MG PO TID, PRN IV VALIUM, AND PERIACTIN 4MG EVERY 6 HOURS. IT WAS NOTED THAT THE PATIENT EXPERIENCED ALTERED MENTAL STATUS, DRAINAGE/INCISIONAL WOUND OPENING, FEVER AND INCREASED SPASTICITY. THE DEVICE SYSTEM WAS USED TO DELIVER GABLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194937 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Hospitalization| R