BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3994387 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14932
    Event Type
    Injury
    Date Received
    August 8, 2014
    Report Date
    July 16, 2014
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8703W, LOT# J0056628R, IMPLANTED: (B)(6) 2001, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S PUMP POCKET WAS INFECTED AND AN EXPLANT WAS PLANNED. THE PATIENT¿S STATUS WAS REPORTED AS ¿ALIVE-NO INJURY¿. THE DEVICE SYSTEM WAS DELIVERING COMPOUNDED BACLOFEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION LATER REPORTED THE PERIOPERATIVE ANTIBIOTICS WERE ADMINISTERED. THE DIAGNOSIS OF INFECTION WAS DETERMINED, (B)(6). THE PATIENT DID NOT HAVE MENINGITIS. THE DATE OF THE LAST REFILL WAS NOTED AS (B)(6) 2014. THE SYMPTOMS THE INFECTION WERE RED PUMP POCKET AND RADIATING OUTWARD, THE LOCATION WAS THE PUMP POCKET AND SURROUNDING FEW INCHES. A CULTURE OF THE PUMP POCKET WAS OBTAINED AND THE ORGANISM CULTURED (B)(6). PER THE REPORTER THE PATIENT WAS DOING WELL, RECOVERED FROM INFECTION AND DOING WELL ON ORAL BACLOFEN. BECAUSE OF LARGE BEDSORE ON THE PATIENT'S "BUTTOM" IT WAS DOUBTFUL THE PATIENT WOULD BE ABLE TO HAVE ANOTHER ITB SYSTEM IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469795 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R