BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3251720 · Received July 29, 2013

    Report

    Report Number
    3004209178-2013-12398
    Event Type
    Injury
    Date Received
    July 29, 2013
    Report Date
    July 2, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8784, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: CATHETER. PRODUCT ID: 8782, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: CATHETER. PRODUCT ID: 8835, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP REVEALED NO ANOMALY FOUND. ANALYSIS OF THE CATHETER SEGMENT 8784 REVEALED NO ANOMALY FOUND. ANALYSIS OF CATHETER SEGMENT 8782 REVEALED NO SIGNIFICANT ANOMALY FOUND.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAS A CEREBROSPINAL FLUID (CSF) LEAK PRESENTING WITHOUT NORMAL SYMPTOMS. THE PHYSICIAN BELIEVED THE (CSF) TO BE LEAKING "AROUND THE CATHETER." A DYE STUDY AND X-RAY WERE PERFORMED. AN EXPLANT WAS PLANNED FOR (B)(6) 2013. 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 THE PATIENT EXPERIENCED FLUID COLLECTION AT THE BACK INCISION AND PUMP POCKET. THE CAUSE OF THE EVENT WAS ¿DURAL LEAK MOST LIKELY.¿ THE PUMP AND CATHETER WERE REMOVED. THE PATIENT OUTCOME WAS NO INJURY. THE PATIENT WAS DOING GOOD. THE PLAN WAS TO REPLACE THE PUMP AND CATHETER IN THE FUTURE WHEN THE PATIENT WAS HEALED. THE PUMP WAS DELIVERING FENTANYL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351800 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention