BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3222278 · Received July 12, 2013

    Report

    Report Number
    3004209178-2013-11642
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    December 1, 2012
    Report Date
    June 19, 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
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE CATHETER; PRODUCT ID 8840, SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN. (B)(4).

    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). ALL PREVIOUSLY REPORTED CONCLUSION CODES HAVE BEEN UPDATED/CORRECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT OVER THE LAST SEVERAL VISITS (TIME FRAME OF VISITS UNKNOWN) THE PATIENT COMPLAINED OF INCREASED SPASTICITY. DOSE INCREASES DID NOT RESULT IN CHANGES TO EFFICACY. AN MRI WAS DONE RECENTLY AND EVERYTHING SEEMED NORMAL. THE PATIENT CAME IN MONDAY BEFORE THE DAY OF THE REPORT FOR A REFILL AND THE HCP EXPECTED 3ML AND PULLED OUT BARELY .5 ML. THE PATIENT WAS REFILLED AND RESTARTED ON THE SAME DOSE THAT HE HAD BEEN ON. THE MORNING THE DAY OF THE REPORT THE PATIENT WAS LETHARGIC AND UNABLE TO BE AROUSED. THE PATIENT WAS INTUBATED AND ON HIS WAY TO THE ER. NO PREVIOUS VOLUME DISCREPANCIES REPORTED. THE PATIENT HAD BEEN ON A STABLE DOSE UNTIL RECENTLY. THE PUMP WAS USED TO DELIVER GABLOFEN. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT WAS IN ER WITH OVERDOSE SYMPTOMS. PER THE REPORTER THE PATIENT FELT LIKE THEY WERE EXPERIENCING "UNDERDOSE" GOING BACK TO (B)(6) 2013. THE PATIENT WAS REFILLED IN (B)(6) 2012 AND EVERYTHING WENT GREAT. THEN PATIENT CALLED THE HCP IN (B)(6) WITH AN INCREASE IN SPASTICITY BUT BY THE TIME THE PATIENT CAME TO OFFICE THEY WERE FEELING JUST FINE. FEW DAYS AFTER THAT - MORE INCREASE IN SPASTICITY - DYE STUDY AND X-RAY SHOWED NO ISSUES. THE PATIENT¿S SPASTICITY HADN¿T REALLY IMPROVED SINCE (B)(6). THE PATIENT WAS NOT ON A REALLY HIGH DOSE. THE PATIENT EXPERIENCED INCREASING SPASTICITY AT NIGHT AND ALSO STARTED TAKING ORAL BACLOFEN. WHEN THE PATIENT CAME IN FOR A REFILL ON THAT MONDAY THE HCP ALSO INCREASED BASAL RATE AS WELL. IT WAS ALSO NOTED THAT THE HCP PROGRAMMED 40 MLS IN THE RESERVOIR VOLUME BACK IN (B)(6) BUT ONLY ACTUALLY FILLED WITH 20 MLS. IT WAS BELIEVED THAT WAS WHY NO ALARM WAS HEARD AND WHY THE PATIENT MAY HAVE FELT LIKE HE WAS NOT GETTING ENOUGH DRUG AND WHY THE PATIENT WOULD BE GOING THROUGH OVERDOSE IF THEY STARTED HIM RIGHT BACK UP AT PREVIOUS DOSE AND THE PUMP HAD BEEN EMPTY OR NEARLY EMPTY. THE PUMP WAS PROGRAMMED IN MIN RATE MODE UNTIL PATIENT STABILIZED AND THEN THE HCP WOULD START THE PATIENT OUT ON A LOWER DOSE.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT EXPERIENCED INCREASED SPASTICITY, AS THE PUMP RAN OUT. THE PATIENT NOTED ¿SOME¿ BENEFIT TO THE INCREASED DOSE, BUT IN RETROSPECT, THE PUMP WAS EMPTY. WHEN THE PUMP WAS REFILLED, THE RATE WAS INCREASED AND THE PATIENT EXPERIENCED OVERDOSE. THE PREVIOUSLY REPORTED PROGRAMMING ERROR WAS NOT CAUGHT UNTIL THE REFILL LEAD TO OVERDOSE. THE PATIENT HAD INPATIENT OBSERVATION; THE PATIENT REQUIRED HOSPITALIZATION. THE PATIENT WAS OBTUNDED, EXPERIENCED RESPIRATORY DEPRESSION AND WAS VENTED OVERNIGHT. THE PUMP WAS PROGRAMMED TO MINIMUM RATE AND THE DOSE WAS SLOWLY INCREASED ON AN OUTPATIENT BASIS. THE PATIENT OUTCOME WAS REPORTED AS ¿NO INJURY¿. HE DID NOT HAVE ANY SYMPTOMS AT THE TIME OF THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321476 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00024 YR Hospitalization| L| R