BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3367144 · Received September 25, 2013

    Report

    Report Number
    3004209178-2013-16877
    Event Type
    Injury
    Date Received
    September 25, 2013
    Date of Event
    July 13, 2013
    Report Date
    September 10, 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
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8578 LOT# N131626, IMPLANTED: 2008 (B)(6); PRODUCT TYPE ACCESSORY PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE CATHETER. (B)(4). EVALUATION SUMMARY - ANALYSIS OF THE PUMP REVEALED NO ANOMALY FOUND. THE PUMP PASSED ALL NON-DESTRUCTIVE LAB TESTING AND NOTHING SIGNIFICANT WAS FOUND IN DESTRUCTIVE ANALYSIS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION/DEVICE EVALUATION: PER THE PUMP LOGS, AT THE TIME OF EXPLANT, THE PUMP WAS DELIVERING HYDROMORPHONE (DILAUDID) AND BUPIVACAINE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STARTING OVER THE WEEKEND, THE PUMP STARTED ACTING STRANGE. ON SATURDAY, THE PATIENT NOTICED A GRINDING SOUND; THE PATIENT¿S SPOUSE SAID IT SOUNDED LIKE THE GEARS WERE STUCK. THE PATIENT FELT NAUSEOUS AND WAS HAVING PAIN. SHE WENT TO BED AND FELT THE SAME WHEN WAKING UP THE NEXT DAY; THE PUMP WASN¿T GRINDING ANYMORE, BUT WAS MAKING A LOUD CLICK. THE PAIN WAS MUCH WORSE; THE PATIENT WAS IN TEARS. THE PUMP WAS CHECKED BY A NURSE AND IT DIDN¿T TELL HER ANYTHING OTHER THAN THAT THE PUMP WAS WORKING. IT WAS LAST FILLED 1.5 WEEKS AGO AND ERI (ELECTIVE REPLACEMENT INDICATOR) WAS 18 MONTHS. THE PUMP WAS DELIVERING DILAUDID. IT WAS LATER REPORTED THAT WHEN THE NURSE WAS DEALING WITH THE PATIENT ON (B)(6) 2013 AND (B)(6) 2013 THE PATIENT STATED THAT EVERYTHING WAS THE SAME WITH HER PAIN LEVEL BUT THEN "CHANGED HER STORY" AND SAID, SHE WAS IN MORE PAIN AFTER THE NURSE INQUIRED ABOUT IT. THE PATIENT RATED HER PAIN LEVEL THE SAME PRIOR TO THE EVENT AND FOLLOWING THE EVENT; THERE WAS NO CHANGE IN THE PATIENT¿S PAIN SCORE. THE PATIENT WENT OUT TO DINNER ON (B)(6) 2013 AND BEGAN HAVING PAIN AFTER THAT. THE EVENT LOGS AND PROGRAMMING WERE NORMAL. THERE HAD BEEN NO RESERVOIR VOLUME DISCREPANCIES. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT THE PUMP WAS REPLACED BECAUSE, THE PATIENT THOUGHT SHE HEARD GRINDING NOISES AND HAD AN INCREASE IN PAIN. FOLLOWING THE REPLACEMENT, THE PATIENT RECOVERED WITHOUT SEQUELA.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PUMP "QUIT WORKING" IN (B)(6) 2013. THE PATIENT WENT ON AN AIRPLANE TRIP TO (B)(6) AND WAS BEDRIDDEN FOR A WEEK. THE PATIENT CAME BACK AND WAS "REALLY BAD." THE PUMP COULD BE HEARD GRINDING. THE PATIENT WENT TO A DOCTOR AND THE PUMP WAS CHECKED. IT WAS DETERMINED THE PUMP QUIT WORKING AND THE PATIENT WAS IMMEDIATELY TAKEN FOR REPLACEMENT SURGERY. THE ISSUE WAS BLAMED ON THE ALTITUDE. AT THE TIME OF THE EVENT THE PUMP WAS BEING USED TO DELIVER DILAUDID, HOWEVER THE PUMP WAS PREVIOUSLY USED TO DELIVER MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483964 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Required Intervention