BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2882071 · Received December 20, 2012

    Report

    Report Number
    3004209178-2012-12095
    Event Type
    Injury
    Date Received
    December 20, 2012
    Report Date
    November 20, 2012
    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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ALL PREVIOUSLY REPORTED PATIENT AND DEVICE CODES WILL BE UPDATED/CORRECTED TO THE FOLLOWING FOR THIS EVENT: (B)(4) (SHOCKED AT CONDITION OF BODY), (COULD NOT EAT) (B)(4).

    Additional Manufacturer Narrative · 1

    PATIENT PROGRAMMER MODEL ID (B)(4), SERIAL # (B)(4), IMPLANTED: NA, EXPLANTED: NA; CATHETER MODEL 8711, LOT # N187001014, IMPLANTED: (B)(6) 2009. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CHANGE IN THERAPEUTIC EFFECT OCCURRED. IT WAS NOTED THAT THE PATIENT HAD BEEN RECEIVING MORPHINE IN HER DEVICE FOR FOUR YEARS "WITH NO ISSUES." THE DRUG WAS "SWITCHED' TO FENTANYL ON (B)(6) 2012, AT WHICH TIME THE HEALTH CARE PROVIDER NOTED THAT THE DEVICE ALARM "HAD BEEN GOING OFF EVERY HOUR FOR EIGHT HOURS" AND THE PATIENT HAD NOT HEARD IT. THE CAUSE OF THE ALARM WAS NOT REPORTED. THE PATIENT HAD BEEN FEELING LIKE SHE WAS "DYING" SINCE FENTANYL WAS PLACED IN THE PUMP, SHE WAS "SICK AS A DOG," "COULD NOT EAT," AND HER SKIN "WAS ON FIRE." THE WEEK PRIOR TO THIS REPORT, THE CONCENTRATION WAS CHANGED. THE NEXT DAY THE PATIENT "COULD NOT WAKE UP." IT WAS NOTED THE PATIENT WOKE UP AT 6AM, "DID NOT HAVE STRENGTH" AND "COULD NOT MOVE UNTIL 12 NOON." THE PATIENT CALLED 911 AND WAS ADMITTED TO THE HOSPITAL. PATIENT THOUGHT THERE MAY BE A MALFUNCTION WITH HER DEVICE "EVEN THOUGH SHE WAS FINE UP UNTIL FENTANYL WAS PUT IN." IT WAS LATER REPORTED THAT THE MEDICATION WAS SWITCHED BACK TO MORPHINE. IT WAS ALSO NOTED THAT THE PATIENT WAS "SHOCKED AT THE CONDITION OF HER BODY," THAT IT WAS "GETTING MUCH WORSE," AND THAT SHE NEEDED THE PUMP. IT IS UNCLEAR WHAT WAS MEANT BY HER BODY WAS GETTING WORSE. IT WAS THEN STATED THE PATIENT DID NOT "APPRECIATE WITHDRAWAL" AND THAT SHE "REFUSES TO GO THROUGH IT EVER AGAIN." IT IS UNCLEAR WHEN THE PATIENT EXPERIENCED WITHDRAWAL. IT WAS ALSO NOTED THAT THE PATIENT WAS CONCERNED ABOUT HAVING A PHYSICIAN WHO COULD BE "TRUSTED." A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN. THE PATIENT STATED, "I HAVE FELT AT TIMES IF I HAD A GUN, I WOULD HAVE SHOT MYSELF".

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization