BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3023876 · Received March 27, 2013

    Report

    Report Number
    3004209178-2013-04303
    Event Type
    Injury
    Date Received
    March 27, 2013
    Report Date
    February 27, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, SERIAL # (B)(4), EXPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION, AND A WOUND THAT WAS OPEN AT THE PUMP SITE WITH PURULENT DISCHARGE. CULTURES FROM THE DEVICE POCKET AND FROM BLOOD WERE TAKEN AND WERE BEING PROCESSED. THE PATIENT WAS PUT ON ANTIBIOTIC TREATMENT, AND THE ONSET OF THE INFECTION WAS REPORTED TO BE (B)(6) 2013. THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU) WITH "WITHDRAWAL INFORMATION ON HIS CHART." IT WAS NOTED THAT THE PATIENT EXPERIENCED INCREASED SPASTICITY AND WAS QUADRIPLEGIC. THE PUMP AND CATHETER WERE EXPLANTED. ADDITIONAL INFORMATION WAS PROVIDED THAT THE PATIENT HAD A DRAIN THAT WAS REMOVED FROM THE PUMP SITE, AND THE PATIENT WAS NOTED TO STILL BE IN THE MEDICAL INTENSIVE CARE UNIT (MICU). THE PATIENT HAD RECEIVED TREATMENT FOR WITHDRAWAL WITH INCREASED ORAL BACLOFEN AND CLONAZEPAM. THE PATIENT WAS IMPROVING SLOWLY PER THE NEUROSURGEON. THE PUMP WAS BEING USED TO DELIVER LIORESAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125119 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R