BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3841317 · Received May 30, 2014

    Report

    Report Number
    3004209178-2014-09924
    Event Type
    Injury
    Date Received
    May 30, 2014
    Report Date
    May 7, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE CATHETER; PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FIRST TIME WITHDRAWAL STARTED FOR THE PATIENT WAS IN (B)(6) 2014 AFTER A REFILL. IT WAS NOTED THAT THE PATIENT STARTED FALLING ASLEEP, FELT SLUGGISH AND FATIGUED AND WAS SPENDING A LOT OF TIME IN BED. IT WAS NOTED THAT THE PATIENT FELT LIKE THEY WERE COMING DOWN WITH THE FLU ON (B)(6) 2014. PATIENT WAS DEHYDRATED AND ¿DREAMING ABOUT DEATH.¿ IT WAS ALSO NOTED THAT THE PATIENT COULD NOT ¿CONTROL ARMS AN LEGS.¿ PATIENT WENT INTO THE EMERGENCY ROOM (ER) AND THEY COULD NOT FIND ANYTHING WRONG AND TOLD THE PATIENT GO SEE A PSYCHIATRIST. IT WAS NOTED THAT WHEN THE PATIENT WAS IN THE HOSPITAL, THEY PULLED OUT THE MEDICATION FROM THE PUMP, ¿THERE WAS SUPPOSED TO BE 6.2 LEFT IN THE PUMP BUT 13.2 WAS ASPIRATED.¿ IT WAS NOTED THAT THE PATIENTS SYMPTOMS NEVER REALLY WENT AWAY. ON (B)(6) 2014, PATIENT¿S HEADACHE (MIGRAINES) AND NAUSEA WERE COMING BACK. PATIENT HAD DIARRHEA AND THEIR LEGS AND ARMS WERE SHAKING AND ¿OTHER NAMELESS SYMPTOMS.¿ IT WAS NOTED THAT THE REFILL DATE MOVED FROM ¿(B)(6).¿ IT WAS NOTED THAT THE HEALTHCARE PROVIDER RECOMMENDED A ¿PUMPOGRAM (DYE STUDY)¿ FROM THE MANUFACTURER.¿ THE PATIENT WAS ON NEURONTIN FOR THEIR LEGS AND ARMS FROM ¿JITTERING.¿ THE PUMP SYSTEM WAS DELIVERING HYDROMORPHONE AND BUPIVACAINE. IT WAS LATER REPORTED THAT THE PATIENT WAS SUPPOSED TO HAVE AN APPOINTMENT TO HAVE HER ¿PUMP CHECKED/DYE STUDY¿ WITH THE HEALTH CARE PROVIDER (HCP) AT 1:30PM ON (B)(6) 2014 BUT THE APPOINTMENT WAS CANCELLED AND RESCHEDULED FOR (B)(6) 2014 AT 1PM. THEY REPORTEDLY ARE GOING TO CHECK HER PUMP TO SEE IF THE CATHETER IS KINKED. IT WAS THEN REPORTED THE PATIENT STARTED TO HAVE MORPHINE WITHDRAWAL SYMPTOMS ¿ABOUT THREE WEEKS AGO¿ INCLUDING HEADACHES/MIGRAINES, NAUSEA AND DIARRHEA. THE PATIENT¿S HCP HAD DIRECTED THE PATIENT TO CONTACT THE DEVICE MANUFACTURER TO REQUEST A DEVICE MANUFACTURER REPRESENTATIVE BE PRESENT AT THE UPCOMING APPOINTMENT. NO FURTHER INFORMATION WAS PROVIDED. IT WAS FURTHER REPORTED THE PATIENT WAS HAVING DIFFICULTY WITH ¿MORPHINE WITHDRAWAL¿ THAT HAD STARTED AT THE END OF (B)(6). ¿ABOUT THE THIRD WEEK IN (B)(6)¿ THE PATIENT WAS WORKING ON HER COMPUTER AND WAS FALLING ASLEEP. SHE WAS HOSPITALIZED IN FEBRUARY. ON (B)(6) 2014, THE PATIENT STATED FEELING REALLY SICK, SHE HAD THE CHILLS, A FEVER, DIARRHEA SEVERE HEADACHES AND WERE LEGS AND ARMS WERE PUMPING UNCONTROLLABLY. THE PATIENT WAS STILL HAVING THE SYMPTOMS. IT WAS THEN REPORTED THE PREVIOUSLY REPORTED DISCREPANCY OF EXPECTING 6.2ML BUT RECEIVING 13ML OCCURRED IN (B)(6). THEN, ON (B)(6) 2014, THE HCP WAS EXPECTING 6.2ML AND TOOK OUT 9ML. THE DEVICE MANUFACTURER REPRESENTATIVE REPORTEDLY ¿FINALLY CAME OUT¿ ON (B)(6) 2014 AND IT WAS REPORTED THEY WERE ¿SUPPOSED TO BE CHECKING FOR A ¿KNOT¿ BUT THE REP DIDN¿T BRING HER STUFF.¿ THE REPRESENTATIVE REPORTEDLY DIDN¿T DO ¿ANYTHING.¿ THE TEST THAT WAS TO BE PERFORMED WAS REPORTEDLY CALLED A ¿ROTARY DYE STUDY¿ AND IT WAS THEN REPORTED THEY WOULD BE TESTING THE CATHETER. IT WAS REPORTED THE DRUG INFORMATION, HYDROMORPHONE AND BUPIVACAINE PROVIDED WAS FROM THE PATIENT¿S PRINTOUT DATED (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318750 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Hospitalization