BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3200850 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-11153
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    February 27, 2013
    Report Date
    June 6, 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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: CATHETER MODEL: 8703W, LOT# L51342, IMPLANTED: (B)(6) 1999, EXPLANTED: UNK. (B)(4).

    Description of Event or Problem · 1

    VOLUME DISCREPANCIES WERE REPORTED. THE PUMP WAS LAST REFILLED ON (B)(6) 2013. AT THE TIME OF THE REFILL THE RESIDUAL RESERVOIR VOLUME WAS EXPECTED TO BE 5.9 ML, HOWEVER THE ACTUAL RESIDUAL VOLUME OBTAINED WAS 1.0 ML. AT THE DATE OF THIS REPORT STATED THAT PHYSICIAN REPORTEDLY HAD A VOLUME DISCREPANCY AT THAT LAST PUMP REFILL AS WELL (SPECIFICS WERE NOT AVAILABLE). THE PHYSICIAN FELT THEY MAYBE THEY ¿DID SOMETHING DIFFERENT¿ AND DIDN¿T REALIZE IT, OR MAYBE ¿I GOT SOME OF IT SUB-Q, EVEN THOUGH I DIDN¿T THINK I DID¿; THE REPORTER FELT IT WAS UNLIKELY THAT OCCURRED AS THE PHYSICIAN WAS ¿METICULOUS ABOUT THAT¿. THEY WERE CONSIDERING OF SETTING THE LOW RESERVOIR ALARM TO 6MLS. IT WAS NOTED THAT THE PHYSICIAN RECENTLY INHERITED THE PATIENT NOT LONG AGO AND HE DIDN¿T REALLY KNOW HER BASELINE. THE PATIENT¿S SPASTICITY WAS NOT WELL CONTROLLED. IT WAS UNKNOWN TO THE PHYSICIAN IF THE PATIENT¿S SPASTICITY WAS WELL CONTROLLED OR NOT BEFORE HE TOOK ON THE PATIENT¿S CARE. IT WAS BELIEVED THAT THE PATIENT WAS NOT PRESENTING WITHDRAWAL OR OVERDOSE SYMPTOMS, BUT SHE SITS WITH HER LEGS PULLED UP UNDER HER BECAUSE HER HAMSTRINGS ARE SO SPASTIC; ¿THAT¿S HOW SHE WAS¿ UPON VISITING THE PHYSICIAN THE FIRST TIME. THE PHYSICIAN HAD BEEN INCREASING HER DOSE. THE PUMP DOSE WAS INCREASED LAST ON (B)(6) 2013 FROM 350 MCG/DAYTO 405 MCG/DAY. THE PHYSICIAN WAS INITIALLY JUST PERFORMING TITRATIONS, AND IT WAS BELIEVED THE PHYSICIAN HAD ONLY PERFORMED TWO PUMP REFILLS FOR THE PATIENT. A SINGLE BOLUS WAS PERFORMED TO SEE HOW THE PATIENT RESPONDED, HOWEVER THE PATIENT DIDN¿T SEEM TO RESPOND TO THE BOLUS. THE PHYSICIAN WAS CONSIDERING WHETHER OR NOT TO TRY A SIMPLE CONTINUOUS PUMP DOSE VS. ADMINISTERING BOLUSES VIA THE PUMP. IT WAS STATED THAT EITHER PATIENT JUST WASN'T GETTING ENOUGH DOSE OR MAYBE THERE WAS A CATHETER ISSUE, WHICH IS ONE OF THE REASONS THE PHYSICIAN HAD TRIED A SINGLE BOLUS. BUT SHE HAD A GREAT RESPONSE. THE PATIENT WAS DESCRIBED AS BEING AN AVID SUNBATHER,HOWEVER IT WAS UNKNOWN THE PATIENT USED TANNING BEDS/OTHER IN REGARDS TO A POTENTIAL SOURCE OF HEAT HAVING BEEN INTRODUCED TO THE PUMP. DRUG DELIVERED VIA THE DEVICE WAS LIORESAL (2000 MCG/ML) AT A DOSE RATE OF 405 MCG/DAY. IT WAS LATER REPORTED THAT ON (B)(6) 2013, THE PATIENT WAS FIRST SEEN BY HER CURRENT PUMP MANAGING PHYSICIAN WHEN A PUMP VOLUME DISCREPANCY WAS DISCOVERED. THE EXPECTED RESERVOIR VOLUME WAS 5.9 ML AND THE ACTUAL RESERVOIR VOLUME WAS 0.5 ML. AT THAT APPOINTMENT, THE LOW RESERVOIR VOLUME INDICATOR WAS CHANGED TO 4 MLS. THE PATIENT WAS BEING TREATED WITH 235 MCG/DAY AND THE DAILY DOSE WAS INCREASED TO 260 MCG. THE PATIENT WAS SEEN AGAIN ON (B)(6) 2013, AND THE PATIENT HAD EXPERIENCED WORSENING SPASTICITY AND HAD A UTI (URINARY TRACT INFECTION), AND THE PATIENT¿S DOSE WAS INCREASED TO 300 MCG/DAY. ON (B)(6) 2013, THE PATIENT EXPERIENCED NO CHANGE IN THERAPY, AND WAS STILL HAVING A LOT OF SPASTICITY. BECAUSE THE PATIENT SAW NO CHANGE IN SPASTICITY, SHE WAS GIVEN A 25 MCG BOLUS ON (B)(6) 2013 AND HER DAILY DOSE WAS INCREASED TO 350 MCG/DAY. ON (B)(6) 2013, IT WAS REPORTED THAT APPROXIMATELY SIX HOURS FOLLOWING THE THERAPEUTIC BOLUS THAT WAS GIVEN TO THE PATIENT ON (B)(6) 2013, SHE HAD A GREAT RESPONSE. THE PATIENT¿S DAILY DOSE WAS INCREASED TO 405 MCG/DAY AND ALSO INCREASED THE LOW RESERVOIR VOLUME TO 6 MLS. ON (B)(6) 2013, THE PATIENT HAD A DRAMATIC IMPROVEMENT. THE PATIENT USUALLY WAS CROSS LEGGED, AND WASN¿T ABLE TO SIT COMFORTABLY IN A CHAIR, BUT ON (B)(6) 2013, THE PATIENT¿S LEGS HUNG NORMALLY AND DANGLED AT 90 DEGREES OVER HER CHAIR. THE PATIENT'S DAILY DOSE WAS INCREASED 15-17% TO APPROXIMATELY 480 MCG/DAY. THE PATIENT WAS EDUCATED ON WITHDRAWAL, ALARMS, AND THE PATIENT WAS GIVEN ¿PO.¿ REPLACING THE PUMP WAS CONSIDERED A POSSIBILITY, AND THE PATIENT WAS GOING TO BE SEEN AGAIN ¿EARLY.¿ IN REGARDS TO HEAT THERAPY IT WAS CONFIRMED THAT PATIENT HAD NONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303344 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00044 YR