BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2790526 · Received October 15, 2012

    Report

    Report Number
    3004209178-2012-09201
    Event Type
    Injury
    Date Received
    October 15, 2012
    Report Date
    September 21, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8835, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER PRODUCT ID 8590-9, LOT# N231458, IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2012, PRODUCT TYPE ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2011, PRODUCT TYPE CATHETER; PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2011, PRODUCT TYPE CATHETER; PRODUCT ID 8590-9, LOT# N231458, IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2011, PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT¿S DEVICE SYSTEM WAS REMOVED (B)(6) 2011 DUE TO AN INFECTION. THE ONSET OR DIAGNOSIS OF INFECTION WAS (B)(6) 2011. THE PATIENT HAD MENINGITIS AND IT WAS NOTED SHE ALSO HAD A HISTORY OF BACTERIAL MENINGITIS. THE PATIENT EXPERIENCED FEVER, REDNESS, SWELLING, AND PAIN. THE PRIMARY LOCATION OF THE INFECTION WAS UNKNOWN BUT CULTURES OBTAINED FROM THE DEVICE POCKET REVEALED THE PATIENT HAD (B)(6). IT WAS ALSO NOTED THE PATIENT HAD A HISTORY OF MRSA. THE PATIENT WAS TREATED WITH INTRAVENOUS AND ORAL ANTIBIOTICS AND TOTAL DEVICE SYSTEM EXPLANT. THE PATIENT¿S INFECTION RESOLVED AND IT WAS NOTED THE PATIENT DID NOT EXPERIENCE DRUG WITHDRAWAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE SYSTEM WAS REMOVED DUE TO INFECTION. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR Required Intervention