BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4130645 · Received September 30, 2014

    Report

    Report Number
    3004209178-2014-18013
    Event Type
    Injury
    Date Received
    September 30, 2014
    Report Date
    September 5, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: 2013-(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

    ANALYSIS OF THE PUMP SERIAL NUMBER (B)(4) FOUND GEAR TRAIN ANOMALY, CORROSION AND/OR WEAR AND/OR LUBRICATION. ANALYSIS OF THE PUMP FOUND GEAR TRAIN ANOMALY, STALL DUE TO SHAFT-BEARING. (B)(4)

    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 DURING A SIDE PORT DYE STUDY THE HEALTHCARE PROFESSIONAL (HCP) WAS NOT ABLE TO ASPIRATE THE CATHETER. THE DYE STUDY WAS PERFORMED BECAUSE THE PATIENT HAD VOLUME DISCREPANCIES AT THEIR LAST 3 REFILLS. THE PATIENT HAD A "SIGNIFICANT REDUCTION OF PAIN RELIEF" OVER THE SAME PERIOD OF TIME. THE HCP GOT BACK 5 ML "AT BEST" AND 10 ML "AT THE WORST DISCREPANCY". THE PATIENT WAS HAVING "EPISODES" WITH "NO RHYME OR REASON OR PATTERN". THE PATIENT WOULD BE FINE FOR A FEW DAYS, THEN THEY FELT LIKE THEY WERE NOT GETTING MEDICATION. THE PATIENT "COULD TELL" WHEN THEY WERE NOT GETTING MEDICATION BECAUSE THEY WOULD NOT FEEL RELIEF. LOGS WERE CHECKED AND LOOKED FINE. A ROTOR STUDY WAS PERFORMED AND THE ROTOR TURNED "JUST FINE". IT WAS STATED, "MOST OF THE MEDICATION [WAS] BEING DELIVERED SO PUMP [WAS] TRYING TO DISPENSE THE MEDICATION". THE PATIENT WAS ON FLEX PROGRAMMING BUT CONFIRMED THE EPISODES OF LOSS OF THERAPY DID NOT CORRELATE TO THE FLEX PATTERN. THE PATIENT HAD GREAT RELIEF WHEN THEY WERE FIRST IMPLANTED AND BEGAN TO PLAY GOLF AGAIN. THE MANUFACTURER REPRESENTATIVE WONDERED IF THE PATIENT "OVERDID IT" AND CAUSED AN ISSUE WITH THE CATHETER. THE PATIENT WAS WEANED OFF MEDICATION IN PREPARATION FOR A CATHETER REVISION. BUPIVACAINE WAS REMOVED FROM THE MIX. THE SYSTEM WAS REMOVED AND THE PATIENT RECOVERED WITHOUT SEQUELAE. THE PUMP WAS USED TO DELIVER BUPIVACAINE AND MORPHINE. THE PATIENT WAS TAKING DILAUDID ORALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607222 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Required Intervention