BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3251441 · Received July 29, 2013

    Report

    Report Number
    3004209178-2013-12385
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    June 28, 2013
    Report Date
    July 3, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8780, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER; 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 THE PATIENT¿S PUMP AND CATHETER WERE EXPLANTED DUE TO A SUSPECTED CSF (CEREBRAL SPINAL FLUID) LEAK AND AN INFECTION IN THE PUMP POCKET. DRAINAGE AT THE POCKET INCISIONAL WOUND OPENING WAS OBSERVED. A CULTURE WAS TAKEN FROM THE DEVICE POCKET, AND THE INFECTION WAS SPECIFIED TO BE A STAPH INFECTION. IT WAS LATER REPORTED THE CSF LEAK WAS CONFIRMED AND AFTER REMOVING THE CATHETER, THE PATIENT WAS DOING FINE. THE INFECTION HAD BEEN MANAGED, AND THE PATIENT WAS GOING TO HAVE A PUMP AND CATHETER RE-IMPLANTED ONCE EVERYTHING HAD HEALED. ADDITIONAL INFORMATION LATER RECEIVED REPORTED THE HEALTH CARE PROVIDER (HCP) INDICATED THE ONSET/DIAGNOSIS OF THE INFECTION WAS (B)(6) 2013. THE PATIENT DID NOT HAVE MENINGITIS. SIGNS AND SYMPTOMS INCLUDED FEVER, REDNESS, SWELLING, DRAINAGE, AND PAIN. THE PRIMARY LOCATION OF INFECTION WAS THE DEVICE POCKET. CULTURES WERE ACQUIRED FROM THE DEVICE POCKET AND BLOOD. THE TYPE OF ORGANISM CULTURED WAS STAPHYLOCOCCUS AUREUS . THE PATIENT RECEIVED IV ANTIBIOTICS. THE INFECTION RESOLVED. THE PUMP WAS USED TO DELIVER LIORESAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352956 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00008 YR Required Intervention