BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3931641 · Received July 14, 2014

    Report

    Report Number
    3004209178-2014-12949
    Event Type
    Injury
    Date Received
    July 14, 2014
    Report Date
    June 23, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1151-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE CATHETER PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    LAST WEEK, THE PATIENT¿S LEG WENT NUMB AND IT WAS DETERMINED THAT THE PATIENT HAD SEVERE OSTEOMYELITIS (BONY INFECTION OF THE VERTEBRA). THE PATIENT ALSO HAD A SOFT TISSUE TYPE GRANULOMA THAT THE CATHETER WENT RIGHT THROUGH SO THE CATHETER WAS CUT AND TIED OFF. THE PUMP POCKET WAS FINE. THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN. ADDITIONAL INFORMATION INDICATED THAT PERI-OPERATIVE ANTIBIOTICS HAD BEEN ADMINISTERED. THE ONSET OF INFECTION WAS (B)(6) 2014. THE PRIMARY LOCATION OF THE INFECTION WAS THE LUMBAR REGION. IT WAS NOTED THAT THE PATIENT DID NOT HAVE MENINGITIS. THE PATIENT HAD BEEN UNABLE TO MOVE THE RIGHT LEG SO AN MRI (MAGNETIC RESONANCE IMAGING) WAS PERFORMED AND SHOWED OSTEOMYELITIS AT L2-L3. A CULTURE OF THE LUMBAR REGION WAS PERFORMED AND AS OF (B)(6) 2014 THE RESULTS WERE NEGATIVE. TREATMENT INCLUDED INTRAVENOUS ANTIBIOTICS, LUMBAR LAMINECTOMY, REMOVAL OF INFECTED TISSUE AND REMOVAL OF BACLOFEN PUMP TUBING. THE REPORTER DID NOT KNOW THE DATE OF THE LAST REFILL. THE PATIENT¿S RISK FACTORS PRIOR TO IMPLANT OF THE DEVICE SYSTEM INCLUDED URINARY TRACT INFECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411153 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Required Intervention