BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3160086 · Received June 10, 2013

    Report

    Report Number
    3004209178-2013-10051
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Report Date
    May 28, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE CATHETER; PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WANTED A STRONGER CONCENTRATION OF BACLOFEN; HOWEVER, THE PATIENT NOTED BEING TOLD THAT THE HEALTH CARE PROVIDER (HCP) DID NOT WANT TO INCREASE IT FOR FEAR OF CLOGGING THE SYSTEM. IT WAS LATER REPORTED THAT DURING THE PATIENT'S REFILLS, THE HEALTH CARE PROVIDER (HCP) WAS PULLING OUT MORE MEDICATION THAN WHAT SHOULD BE THE PUMP. THE PATIENT NOTED THAT TWO REFILLS AGO, THE HCP SAID THE EXPECTED RESIDUAL VOLUME (ERV) SHOULD HAVE BEEN 1 ML AND THE ACTUAL RESIDUAL VOLUME (ARV) WAS ¿WAY OVER¿ AND THE PATIENT WAS NOT ABLE TO GET IT FILLED. THEN THE PATIENT NOTED THAT ON APPROXIMATELY (B)(6) 2013, THE PATIENT WAS ¿WAY OVERDUE¿ FOR A REFILL, AND THE ERV WAS 1 ML AND THE ARV WAS 5 ML. THE PATIENT NOTED THE HCP ONLY FILLED IT WITH 20 ML, AND FOR THE NEXT REFILL ON APPROXIMATELY (B)(6) 2013, THE ERV WAS 4.5 ML AND THE ARV WAS 5.6 ML. THE PATIENT REPORTED HE WAS GETTING GOOD THERAPY. THEN THE PATIENT NOTED HE HAD A DYE STUDY ON APPROXIMATELY (B)(6) 2013 AND THE HCP FOUND SOMETHING WRONG WITH THE CATHETER; THAT THE MEDICATION WAS NOT GOING TO THE PATIENT¿S SPINE. THE HCP THEREFORE TOLD THE PATIENT HE NEEDED SURGERY TO REPLACE EITHER THE PUMP OR THE CATHETER, BUT THEY AGREED TO WAIT 3 WEEKS AND THEN RE-EVALUATE AT THAT TIME. THE NEXT REFILL DATE WAS (B)(6) 2013 AND THE HCP HAD NOT YET SCHEDULED THE PATIENT SURGERY. THE PATIENT AGAIN REQUESTED A HIGHER LEVEL CONCENTRATION IN THE PUMP TO AVOID NEEDING TO GET A REFILL EVERY 7 WEEKS. THE PATIENT WAS REFERRED TO HIS HCP. THE DRUG IN THE PUMP WAS LIORESAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260818 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1