BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3242997 · Received July 23, 2013

    Report

    Report Number
    3004209178-2013-12178
    Event Type
    Injury
    Date Received
    July 23, 2013
    Report Date
    June 28, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8780 LOT# SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE CATHETER PRODUCT ID 8780 LOT# SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), EXPLANTED: 2013 (B)(6), 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 WAS IMPLANTED A COUPLE OF WEEKS PRIOR TO THE REPORT AND THE HEALTHCARE PROVIDER (HCP) BELIEVED THE PUMP SITE WAS INFECTED AS THERE WAS AN ABSCESS AROUND IT. THE HCP EXPRESSED CONCERN REGARDING POSSIBLE MENINGITIS INFECTION. THE HCP INQUIRED INTO TURNING THE PUMP OFF AND GIVING THE PATIENT ORAL MEDICATION; HOWEVER, THE HCP WAS UNSURE WHAT NEEDED TO BE DONE. THE DEVICE SYSTEM DELIVERED LIORESAL. IT WAS LATER REPORTED THAT THE PATIENT HAD DEVELOPED A CEREBROSPINAL FLUID (CSF) LEAK FOLLOWING THE PUMP REPLACEMENT. THE PUMP AND CATHETER WERE TO BE EXPLANTED ON THE DAY OF THE REPORT. THE REPORTER STATED THAT THE PUMP AND CATHETER WOUND NOT BE REPLACED UNTIL THE PATIENT WAS HEALED. IT WAS LATER REPORTED THAT THE PUMP AND CATHETER WERE EXPLANTED ON 2013 (B)(6). THE PATIENT HAD A FEVER. A CULTURE WAS TAKEN FROM THE CSF WHICH REVEALED A (B)(6) INFECTION. THE INFECTION WAS NOTED TO HAVE BEEN IN THE DEVICE POCKET AND CATHETER TRACK. THE PATIENT WAS ADMINISTERED ANTIBIOTIC TREATMENT. PATIENT STATUS AT THE TIME OF THE REPORT WAS NO INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT WAS GIVEN PERIOPERATIVE ANTIBIOTICS. IT WAS CONFIRMED THAT THE PATIENT HAD MENINGITIS. SYMPTOMS INCLUDED FEVER, REDNESS, SWELLING AND SEROMA. IT WAS NOTED THAT THE INCISION WAS CLOSED. CULTURES WERE TAKEN FROM THE DEVICE POCKET AND CSF AND RESULTS SHOWED(B)(6). THE PATIENT WAS ALSO GIVEN IV ANTIBIOTICS. THE PATIENT'S THERAPY HAD BEEN WEANED PRIOR TO THE EXPLANT; THEREFORE THE PATIENT DID NOT EXPERIENCE WITHDRAWAL. OUTCOME WAS REPORTED AS INFECTION RESOLVED. IT WAS LATER REPORTED THAT THE PATIENT WAS DOING WELL WITH GOOD CLINICAL RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342338 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00011 YR Required Intervention