BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3781246 · Received April 30, 2014

    Report

    Report Number
    3004209178-2014-08278
    Event Type
    Injury
    Date Received
    April 30, 2014
    Report Date
    April 8, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: 2014 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD NOT RESPONDED TO THERAPY SINCE (B)(6) 2014, DESPITE DOSING INCREASES AND INTRATHECAL BOLUS. IT WAS STATED THAT THE PATIENT HAD DYSTONIA AND WAS BEING WEANED OFF ORAL VALIUM AND TEGRETOL. THE PATIENT WAS TO HAVE A CATHETER ACCESS PORT (CAP) DYE STUDY THE DAY OF THE REPORT. THE REPORTER DENIED ANY ACTIVE ALARMS. THE PUMP HAD NOT BEEN CHECKED FOR A VOLUME DISCREPANCY. THE PUMP WAS USED TO DELIVER BACLOFEN. IT WAS REPORTED THE NEXT DAY THAT THE EVENT LOGS WERE NORMAL. IT WAS REPORTED A WEEK LATER THAT DURING THE DYE STUDY, THE DYE INITIALLY WOULD NOT FLOW OUT OF THE END OF THE CATHETER. IT WAS SUSPECTED THAT THE CATHETER WAS AGAINST AN ELEMENT INSIDE THE INTRATHECAL SPACE OR ARACHNOID POUCH. MORE DYE WAS PLACED AND THE MANUFACTURER REPRESENTATIVE WAS HAD THE IMPRESSION THAT THERE WAS A PROBLEM, BUT THE ¿IR DOCTOR¿ DECIDED THAT THE OCCLUSION WAS CLEARED AND THE DYE WAS FLOWING WELL BY THE END OF THE STUDY. IT WAS ALSO STATED THAT THE PATIENT WAS NOT DOING WELL. THE REPORTER INCREASED THE DOSAGE FROM 500 TO 570 MICROGRAMS (MCG)/DAY WITH MINIMAL RESPONSE. THE DOSAGE WAS THEN INCREASED TO 625MCG/DAY AND THE PATIENT EXPERIENCED RESPIRATORY DEPRESSION. THE REPORTER THEN TURNED THE PUMP OFF FOR SEVERAL HOURS AND TURNED IT BACK ON AT A RATE OF 600MCG/DAY. THE PATIENT AGAIN HAD RESPIRATORY DEPRESSION EVEN THOUGH THE PATIENT DID NOT HAVE ANY RESPONSE TO ONGOING DYSTONIC POSTURING. THERE WAS NO NOTED CHANGE IN VITALS WHEN THE DOSAGE WAS PLACED AT 525MCG/DAY. THE PATIENT¿S PUMP WAS TURNED OFF AGAIN AND THEN BACK ON 8 HOURS LATER. THE PATIENT WAS BEING MONITOR IN THE INTENSIVE CARE UNIT (ICU). THE PATIENT WAS CURRENTLY BACK TO BASELINE AND DYSTONIC POSTURING, LIKE PRIOR TO HAVING THE PUMP PLACED. IT WAS FURTHER STATED THAT THE PATIENT WAS PERFECTLY GREAT AT 375 OR 400MCG/DAY BEFORE SHE STARTED HAVING PROBLEMS 8 DAYS AGO. THE PATIENT WAS PREVIOUSLY ABLE TO LIFT HER ARMS AND LEGS WITHOUT POSTURING AND DID NOT HAVE ANY OF THE DYSTONIA THAT SHE CURRENTLY HAD. THE REPORTER DID NOT BELIEVE THAT THE PATIENT WAS ACCOMMODATING TO THE DOSE THAT QUICKLY. IT WAS NOTED THAT A TRIAL CATHETER WAS PLACED AND ¿EVERYTHING WAS GREAT FOR A WEEK AFTER THAT AND NOW THE PATIENT HAD A VERY LIMITED RESPONSE WITH SIGNIFICANT RESPIRATORY DEPRESSION WITH JUST A 25MC/DAY INCREASE.¿ IT WAS ALSO NOTED THAT THE MANUFACTURER REPRESENTATIVE WAS UNDER THE IMPRESSION THAT THEY WERE GOING TO EXPLORE THE CATHETER PLACEMENT. HOWEVER, THE NEUROSURGEON AND ¿IR DOCTOR¿ REVIEWED THE STUDY AND CONCLUDED THAT IT WAS WORKING, CONTRARY TO THE MANUFACTURER REPRESENTATIVE¿S OPINION. THE MANUFACTURER REPRESENTATIVE THOUGHT THAT THE DYE DID NOT DISSIPATE INTO THE CEREBROSPINAL FLUID (CSF) LIKE ONE WOULD EXPECT. THE ISSUE BEGAN THE (B)(6) 2014. THE PATIENT EXPERIENCED HORRIBLE SPASMS, SO THE PATIENT WAS GIVENA BOLUS AND THE RATE WAS INCREASED. THE PATIENT WAS REPORTEDLY ¿A MESS¿ THE ENTIRE WEEKEND; SO ORAL VALIUM AND ATIVAN WERE GIVEN UNTIL THE DYE STUDY WAS SCHEDULED. IT WAS NOW NOTED THAT THE PUMP DELIVERED GABLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258829 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00009 YR Hospitalization