BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3811359 · Received May 15, 2014

    Report

    Report Number
    3004209178-2014-09007
    Event Type
    Injury
    Date Received
    May 15, 2014
    Report Date
    April 21, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-2380-2008 Z-1575-2013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID: 8709SC, LOT# (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE CATHETER (LOT NO. N186976013) FOUND CORING TEARS AND CUTS IN THE SEAL THAT POSSIBLY ¿CAUSED OCCLUSION NOT MISALIGNED¿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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT AS OF (B)(6) 2014, THE PATIENT WAS DOING PRETTY GOOD. THE PATIENT HAD NO SIDE EFFECTS AND WAS GETTING FAR BETTER RELIEF.

    Description of Event or Problem · 1

    IT WAS REPORTED THE ACTUAL RESIDUAL VOLUME (ARV) WAS A LITTLE OVER 3ML AND THE EXPECTED RESIDUAL VOLUME (ERV) WAS 17ML. IT WAS REPORTED THE PATIENT HAD A ¿SNOTTY NOSE¿ AND INCREASED PAIN 3 WEEKS AGO. IT WAS NOTED THE PATIENT BELIEVED THEY WERE GETTING A COLD, AND THAT WAS WHY THEY EXPERIENCED THOSE SYMPTOMS. IT WAS STATED THEY ATTEMPTED TO DO A DYE STUDY, BUT WERE NOT ABLE TO ASPIRATE THE CATHETER. IT WAS NOTED THEY WERE UNABLE TO DO A ROLLER STUDY SINCE THEY WERE UNABLE TO ASPIRATE THE CATHETER. IT WAS NOTED THEY WERE CONCERNED THE ROLLERS WEREN¿T TURNING. IT WAS STATED THE LOGS WERE READ AND THERE WERE NO ALARMS. IT WAS NOTED THE ROLLERS WOULD BE ASSESSED AT THE REVISION. IT WAS NOTED THE CLINIC FOUND THE PROBLEM ON FRIDAY DURING THE PATIENT¿S REFILL. THE PUMP WAS USED TO DELIVER BUPIVACAINE AND DILAUDID. IT WAS CONFIRMED THE ARV 17ML AND THE ERV WAS JUST OVER 3ML 2 DAYS LATER ADDITIONAL INFORMATION REPORTED THE CATHETER WAS COMPLETELY REPLACED (B)(6) 2014 SINCE THE ATTEMPT TO JUST REVISE IT WAS A FAILURE. IT WAS STATED THE CATHETER WAS NOT PATENT SOMEWHERE BETWEEN THE SIDE PORT AND THE LUMBAR INSERTION SITE. IT WAS NOTED A ROTOR STUDY WAS PERFORMED IN THE OR AND FLUID WAS COMING OUT OF THE PUMP. IT WAS NOTED THE PATIENT WAS SEEING THE DAY OF REPORT FOR POST OP. ADDITIONAL INFORMATION REPORTED IT WAS TOO EARLY TO TELL THE EFFICACY OF THERAPY SINCE THEY NEEDED TO TITRATE UP. IT WAS STATED THEY WERE USING PRIALT MONO THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290346 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00042 YR Required Intervention