BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3151513 · Received June 7, 2013

    Report

    Report Number
    3004209178-2013-08765
    Event Type
    Injury
    Date Received
    June 7, 2013
    Report Date
    May 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCT: PRODUCT ID 8709, LOT# J11037R17, IMPLANTED: (B)(6) 2002, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING SYMPTOMS OF ACUTE PAIN, ¿STOMACH HURTS¿, TROUBLE WALKING, AND INABILITY TO GET COM FORTABLE. THE PATIENT SYMPTOMS STARTED APPROXIMATELY A MONTH PRIOR TO THE REPORT DATE. THE PATIENT INDICATED SPENDING 11 DAYS IN THE HOSPITAL, STARTING A MONTH AGO ALSO, AND WAS ¿REAL SICK¿ WITH WHAT THE HEALTHCARE PROVIDER¿S (HCP) THOUGHT WAS AN INTESTINAL INFECTION. THE PATIENT STATED ¿I THINK MY PUMP HAS STOPPED WORKING¿, OR ¿SOMETHING IS WRONG¿. PATIENT REPORTED ¿DON¿T REMEMBER WHICH ONE TURNS THE PUMP OFF, BUT THEY RAN TESTS ON THAT¿ AND WANTED THE DEVICE CHECKED. THE PATIENT NOTED THAT THE HCP'S DID RUN TESTS ON THE PUMP AND EVERYTHING APPEARED TO BE OK WHILE HOSPITALIZED. THE PATIENT NOTED CONTINUED SYMPTOMS HOWEVER AFTER GETTING OUT OF THE HOSPITAL STILL. THE PATIENT¿S PAIN LEVEL HAD BEEN AT A 9 WHEN IT USUALLY IS AT A 3 OR 4. THE PATIENT FELT AS THEY DID PRIOR TO GETTING THE PUMP IMPLANTED. THE PATIENT DID NOT BELIEVE THEY WERE GOING THROUGH WITHDRAWAL AT THE TIME OF REPORT, BUT WAS SO SICK IN THE HOSPITAL THAT THEY WERE QUESTIONING IF SOME OF THE SYMPTOMS WERE WITHDRAWAL RELATED THEN. IT WAS ALSO REPORTED THAT PATIENT WAS DIABETIC AND WAS WORKING TO CONTROL THE DISEASE PROCESS. THE PATIENT HAD NOT HEARD ANY ALARMS. THE PATIENT HAD A CONCERN THAT THE PUMP WAS NOT WORKING BECAUSE THE PAIN WAS SO HIGH, AND THE PUMP WAS ¿ABSOLUTELY CONTROLLING THE PAIN¿ PRIOR TO NOW. AN ALARM WAS AUDIBLE IN (B)(6) 2009, (THE PATIENT¿S PREVIOUS PUMP) AS THE PATIENT HAD HCP DOING SEVERAL ADJUSTMENTS ON THE PUMP AND HE FORGOT TO ATTEND THE REFILL APPOINTMENT, BUT DID NOT EXPERIENCE WITHDRAWAL AT THAT TIME. THE PATIENT¿S NEXT REFILL APPOINTMENT WAS PLANNED TO BE ON (B)(6) 2013. IT WAS LATER REPORTED THAT THE PATIENT HAD ARRIVED TO A HOSPITAL FOR WHAT WAS A NON-PUMP RELATED ISSUE AND THE PATIENT MENTIONED EXPERIENCING AN INCREASE IN PAIN. A PLAN WAS MADE TO INTERROGATE THE PUMP AND READ PUMP LOGS TO CONFIRM PUMP FUNCTION, AND POSSIBLY ALSO CONFIRM THERE WAS NO VOLUME DISCREPANCY. IT WAS LATER REPORTED THAT THE PUMP WAS INTERROGATED, THERE WERE NO ALARMS AND THERE WERE NO ACCURACY ISSUES. THE PUMP HAD 11.7 ML REMAINING, WAS NOT LOW, DRY AND HAD NO STALLS. IT WAS NOTED THAT THE HCP AT THE HOSPITAL WAS NOT FAMILIAR WITH THE PUMP DEVICE AND DECLINED TO ACCESS THE PUMP TO CHECK RESIDUAL AMOUNTS TO CHECK FOR ACCURACY. THUS IT WAS NOT KNOWN HOW MUCH THE PUMP ACTUALLY CONTAINED. THE PUMP WAS USED TO DELIVER MORPHINE AND BUPIVACAINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PUMP WAS SCHEDULED TO BE EXPLANTED AND REPLACED. IT WAS STATED THAT THE MOTOR HAD BEEN STALLED FOR SIX WEEKS WITHOUT A RECOVERY, THOUGH THE CAUSE WAS UNKNOWN. DURING THOSE SIX WEEKS, THE PATIENT HAD BEEN IN SEVERE PAIN, THOUGH THE PHYSICIAN HAD NOT BEEN SEEN UNTIL THE WEEK PRIOR TO REPORT. THE PATIENT HAD PREVIOUSLY HAD A CHOLECYSTECTOMY AND HAD LOST 37 POUNDS SINCE THE SURGERY. ADDITIONALLY, HE WAS LOOKING VERY TIRED AND HAGGARD. THE PATIENT¿S SPINAL PAIN HAD ALSO GOTTEN WORSE. IT HAD OCCURRED AT A TIME WHEN HE HAD BEEN BASICALLY IMMOBILE FOR A WHILE AND WAS DOING A LOT OF THROWING UP. IT WAS STATED THAT THE PATIENT WAS GIVEN A PRESCRIPTION FOR ORAL DILAUDID FOR THE RESIDUAL PAIN HE HAD IN HIS ABDOMEN FROM THE SURGERY. HOWEVER, IT WAS STATED THAT HE DIDN¿T REALLY NOTICE IT HELPING. DURING A REFILL, 32CC OF MEDICATION WAS ASPIRATED FROM THE PUMP WHEN ONLY 2CC WAS EXPECTED. AS IT APPEARED THE MEDICATION WASN¿T LEAVING THE PUMP, THE RATE WAS TURNED DOWN TO 5MG/DAY. UPON INTERROGATION OF THE DEVICE, THERE WERE NO PUMP ALARMS SEEN. THE PATIENT HAD NOT EXPERIENCED ANY WITHDRAWAL, THOUGH IT WAS NOTED THAT THE ORAL OXYCODONE MAY HAVE ATTENUATED OR PREVENTED IT. AN X-RAY WAS DONE ON (B)(6) AND IT WAS FOUND THAT THE CATHETER WAS INTACT. IT WAS STATED THAT THE PATIENT HAD BEEN GIVEN A THREE MONTH SUPPLY OF OXYCODONE BY THE PHYSICIAN. THE PATIENT OUTCOME WAS NOTATED AS AN ONGOING, SERIOUS INJURY/ILLNESS. IT WAS REPORTED THAT THE DEVICE SYSTEM WAS DELIVERING COMPOUNDED BACLOFEN, MORPHINE, AND MARCAINE. HOWEVER, THE DEVICE LOGS SHOWED IT CONTAINED MORPHINE AND BUPIVACAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252790 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Hospitalization| R