BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3811368 · Received May 15, 2014

    Report

    Report Number
    3004209178-2014-09005
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Report Date
    April 21, 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
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID 8583, LOT# N168072, IMPLANTED: 2009-(B)(6), PRODUCT TYPE ACCESSORY. PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: 2009-(B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A CHANGE IN THERAPY EFFECT. IT WAS NOTED THAT THE PATIENT HAD INCREASED SPASTICITY IN THE LOWER EXTREMITIES. IT WAS REPORTED THAT THE HEALTHCARE PROVIDER (HCP) WAS QUESTIONING IF THERE WAS A PROBLEM WITH THE PUMP IF IT WAS NOT REFILLED PROPERLY. IT WAS NOTED THAT THE PUMP WAS LAST REFILLED 4 WEEKS PRIOR. IT WAS REPORTED THAT THE PATIENT WAS NON-COMPLAINT AND NEVER MAKES APPOINTMENTS. IT WAS REPORTED THAT THE HEALTHCARE PROVIDER WAS WORKING WITH RESIDENT AT THE PATIENT¿S LAST REFILL AND THEY BELIEVE THEY PLACED THE MEDICATION IN THE ABDOMINAL CAVITY AND THEN REFILLED AGAIN WITH 20 ML AND ARE PRETTY SURE THAT THEY WERE IN THE PUMP THIS TIME. IT WAS NOTED THAT THE PATIENT CALLED 3 WEEKS LATER AND SAID THEIR LEG WAS STIFF. IT WAS REPORTED THAT THE PATIENT REFUSED TO COME TO THE EMERGENCY ROOM (ER) SO THE HCP COULD ACCESS THE PUMP UNDER FLUOROSCOPY. IT WAS NOTED THAT THE PATIENT REFUSED TO COME IN THE PRIOR WEEK AS WELL. IT WAS REPORTED THAT THE CLINICIAN PROGRAMMER INDICATED THERE SHOULD BE 15ML IN THE PUMP AND THE HCP PLANNED TO ACCESS THE PUMP. IT WAS NOTED THAT THE EXPECTED RESIDUAL VOLUME (ERV) WAS 15 ML; THE ACTUAL RESIDUAL VOLUME (ARV) WAS 3/10 TO 1 ML. IT WAS REPORTED THAT THE HCP BELIEVED THAT AT THE REFILL APPROXIMATELY THREE WEEKS PRIOR THERE WAS A PARTIAL POCKET FILL OF APPROXIMATELY 16 ML. IT WAS NOTED THAT THE PATIENT DID NOT EXPERIENCE SYMPTOMS OF OVERDOSE BUT BEGAN EXPERIENCING UNDERDOSE/WITHDRAWAL SYMPTOMS OF BOTH LEGS BEING STIFF/INCREASED SPASTICITY AND ITCHING/PRURITUS WHICH BEGAN APPROXIMATELY TWO WEEKS PRIOR. IT WAS NOTED THAT THE HCP INQUIRED ABOUT A "BRIDGING DOSE". IT WAS REPORTED THAT THE MANAGING PHYSICIAN PRESCRIBED A SINGLE BOLUS OF 141.78 MCG WITH DURATION OF 24 HOURS WHICH WAS BELIEVED TO BE SAFE FOR THE PATIENT AND THEY WOULD NOT OVERDOSE. IT WAS NOTED THAT UP TO LAST WEEK LIORESAL WAS BEING DELIVERED BY THE PUMP AND THEN THE HOSPITAL SWITCHED TO PREFILLED SYRINGES. IT WAS REPORTED THAT THE PUMP WAS USED TO INFUSE GABLOFEN, 500 MCG/ML AT 71.33UG/DAY.

    Description of Event or Problem · 1

    PLEASE REFER TO MANUFACTURER REPORT # 3004209178-2014-09006 FOR THE EVENT ASSOCIATED WITH REFILL SCHEDULING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290425 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00043 YR