BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3896693 · Received June 26, 2014

    Report

    Report Number
    3004209178-2014-12078
    Event Type
    Injury
    Date Received
    June 26, 2014
    Date of Event
    February 1, 2014
    Report Date
    June 6, 2014
    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
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), EXPLANTED: 2014 (B)(6); PRODUCT TYPE CATHETER. (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

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

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP, SERIAL NUMBER (B)(4), FOUND NO ANOMALY. ANALYSIS OF THE CATHETER, SERIAL NUMBER (B)(4), FOUND THE SC CONNECTOR WITH CORING-TEARING-CUTS IN SEAL THAT MET LEAK CRITERIA. ANALYSIS OF THE CATHETER FOUND CATHETER BODY USER RELATED HOLE.

    Description of Event or Problem · 1

    SINCE APPROXIMATELY (B)(6) 2014, THE PATIENT HAD EXPERIENCED AN INTERMITTENT INCREASE IN PAIN AND SPASTICITY OVER HIS WHOLE BODY. A DYE STUDY WAS ATTEMPTED ON (B)(6) 2014, BUT THE CATHETER COULD NOT BE ASPIRATED SO THE PLANNED DYE STUDY WAS ABORTED. DURING THE CATHETER REPLACEMENT, WHEN THE SUTURELESS CONNECTOR WAS DISCONNECTED FROM THE EXISTING PUMP THERE WAS A BLACK COLORED CRUST PRESENT ON THE PUMP'S SIDE PORT CONNECTION AREA UNDER THE SUTURELESS CONNECTOR AND WITHIN THE CATHETER AT THE SUTURELESS CONNECTION AREA. AFTER EXPLANT, THE PHYSICIAN ATTEMPTED TO FLUSH/FILL THE CATHETER AFTER EXPLANT AND INITIALLY WAS UNABLE. THE PHYSICIAN CONTINUED TO TRY AND FLUSH THE CATHETER AND SOME BLACK COLORED FLAKES CAME OUT FROM WITHIN THE CATHETER AND THE CATHETER FLUSHED. SOME OF THE BLACK MATERIAL WAS FORCEFULLY REMOVED WITH A SURGICAL INSTRUMENT TO SEND FOR CULTURE AND PATHOLOGY. THE PHYSICIAN THEN DECIDED IT WOULD BE BEST TO REPLACE THE PUMP. THE PATIENT STATUS WAS REPORTED AS ¿ALIVE ¿ NO INJURY¿. THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN, MORPHINE, AND PRIALT. IT WAS LATER REPORTED THAT ANALYSIS OF THE DEBRIS FROM THE SURFACE OF THE PAIN PUMP WAS DEGENERATING BLOOD CLOT AND FIBRINOUS DEBRIS. THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373283 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR Required Intervention