BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3131925 · Received May 29, 2013

    Report

    Report Number
    3004209178-2013-08283
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 30, 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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709, LOT# J11018R51, IMPLANTED: (B)(6) 2002, PRODUCT TYPE CATHETER; PRODUCT ID 8578, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE ACCESSORY; PRODUCT ID NEU_PTM_PROG, SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS PATIENT¿S PUMP WAS REFILLED ON (B)(6) 2013. AT THAT APPOINTMENT THERE WAS REPORTEDLY ¿SOMETHING TO DO WITH THE WAY THEY HAD PROGRAMMED THE BOLUSES IN.¿ IT WAS PROGRAMMED TO ALLOW THE PATIENT TO BOLUSES ¿LIKE EVERY TEN MINUTES OR SOMETHING.¿ THIS REQUIRED THE PATIENT TO RETURN TO THE CLINIC AND THE PROGRAMMING WAS FIXED. THE FOLLOWING DAY THE PATIENT NEEDED A BOLUS AND WHEN SHE HAD TURNED ON THE PERSONAL THERAPY MANGER (PTM) THE DATE WAS (B)(6) 2013. NO ALARMS WERE HEARD BY THE PATIENT. A BOLUS WAS ATTEMPTED BUT WAS DENIED AND THE PATIENT DID NOT REMEMBER IF THERE WAS A CODE OR WHAT THE MESSAGE WAS DISPLAYED. THE PATIENT TURNED OFF THE PTM AND TURNED IT BACK ON AND THEN THE TIME FOR THE NEXT ALLOTTED BOLUS WAS ¿LIKE 3 HOURS AND 33 MINUTES OR SOMETHING.¿ ANOTHER BOLUS WAS ATTEMPTED WITH ¿3 HOURS AND 22 MINUTES AND THE B AND THE X.¿ THE PTM WAS TURNED OFF AND BACK ON YET AGAIN. UPON REBOOT THERE WAS A PICTURE OF A PHONE AND AN ¿X¿ AND THEN A PICTURE OF THE PUMP AND A TRIANGLE WITH AN EXCLAMATION POINT IN IT. THERE WAS ALSO A CHECK AT THE BOTTOM IN A SQUARE AND APPEARED AN ¿X¿ IN BETWEEN TWO PICTURES. THERE WAS NO CODE BUT ONLY PICTURES AND THE REPORTER THOUGHT THIS WAS THE SAME MESSAGE THAT WAS SEEN ALSO INITIALLY. IN ADDITION, THE BOLUS WAS DENIED WITH AND ¿X¿ AND 3 HOURS AND 20 MINUTES NOTED. THE PATIENT DID NOT USE AN ANTENNA. THE PATIENT REPORTED THAT THE PAIN IN HER FOOT HAD STOPPED AND SHE DID NOT KNOW IF THAT WAS COINCIDENCE OR DUE TO THE PATIENT RECEIVING A BOLUS. THE PATIENT WAS TO ADDRESS THE DATE ISSUE WITH HER PHYSICIAN. THIS DEVICE SYSTEM DELIVERED BACLOFEN AND MORPHINE.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THE PERSONAL THERAPY MANAGER (PTM) IS STILL READING (B)(6) 2013. THE NEXT REFILL IS SOMETIME IN (B)(6) AND THE LAST ONE WAS LIKELY IN EARLY (B)(6). THE PATIENT¿S THERAPY IS OKAY AND HER PTM IS STILL ABLE TO DELIVER BOLUSES. IT WAS RECOMMENDED THE PATIENT CONTACT THEIR HCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236268 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR