BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3950239 · Received July 22, 2014

    Report

    Report Number
    3004209178-2014-13358
    Event Type
    Injury
    Date Received
    July 22, 2014
    Report Date
    June 30, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: 2010 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT WAS HAVING EPISODIC CHANGES IN SPASTICITY AND CHANGES IN CONSCIOUSNESS. A DYE STUDY WAS BEING DONE. IT WAS NOTED A PREVIOUS HEALTH CARE PROVIDER (HCP) OF THE PATIENT WAS CONCERNED ABOUT SEIZURES. THE DYE STUDY WAS NORMAL. THE SYSTEM WAS BEING USED TO DELIVER BACLOFEN. IT WAS LATER REPORTED, THE SYSTEM WAS BEING USED TO DELIVER GABLOFEN. THE PATIENT WAS SEEN ON 2014 (B)(6) DUE TO NUMEROUS MEDICAL PROBLEMS IN THE YEARS SINCE 2010. THE PATIENT¿S MOTHER WAS CONVINCED THERE WAS SOMETHING WRONG WITH THE PUMP WHICH WAS CONTRIBUTING TO THE SYMPTOMS. THE PATIENT HAD NUMEROUS HOSPITALIZATIONS FOR FEEDING PROBLEMS WITH COMPLAINTS OF CYCLIC SLEEPINESS AND ABNORMAL BEHAVIOR THAT THE PATIENT DEMONSTRATED DURING PROLONGED IN-PATIENT OBSERVATIONS. THE PATIENT HAD EPISODES WHERE SHE WAS NOT TOLERATING FEEDINGS AT ALL AND ONE POINT WAS EVEN ON TOTAL PARENTERAL NUTRITION (TPN), THOUGH ULTIMATELY THEY WERE ABLE TO GET HER BACK ON TO HER G-TUBE FEEDINGS WHICH SHE WAS TOLERATING. THE PATIENT WAS STILL HAVING SOME VOMITING. THE PATIENT HAD A REPEAT ELECTROENCEPHALOGRAM (EEG) TELEMETRY WITH MILD ABNORMALITIES. THERE WAS NO EVIDENCE OF SEIZURE ACTIVITY, THOUGH A PREVIOUS EEG FROM A MONTH AGO DID SHOW CHANGES THAT HAD NOT BEEN SEEN ON THE PRIOR EEG. THE PATIENT WAS HAVING CYCLICAL CHANGES WHERE SHE WOULD HAVE A DAY OR TWO WHERE SHE SEEMED VERY RELAXED AND THEN BECOME VERY SLEEPY, DIFFICULT TO AROUSE, AND THEN WOULD ALTERNATE WITH BECOMING TIGHTER AND MORE ALERT. THE EPISODES WOULD CYCLE EVERY FEW DAYS AND HAD BEEN GOING ON FOR ABOUT A YEAR. IT WAS REPORTED THAT FOR SOME REASON THE PATIENT DID NOT SEEM TO HAVE THE EPISODES WHILE ADMITTED TO THE HOSPITAL. OVERALL, THE PATIENT HAD DECLINED FUNCTIONALLY OVER THE LAST FEW YEARS. THE PATIENT WAS NO LONGER TRYING TO ASSIST WITH WALKING AND NO LONGER CRAWLED OR WAS ABLE TO SIT UNASSISTED. THE PATIENT NO LONGER ROLLED OVER. THE PATIENT HAD LOST ALL OF THOSE SKILLS IN THE PAST 2 YEARS. THE PATIENT WAS ABLE TO SELF-PROPEL THE WHEELCHAIR FOR SHORT DISTANCES. THE PATIENT HAD MULTIPLE TYPES OF SEIZURES IN WHICH THE MOST PROMINENT WAS WHEN SHE TENSED UP HER ARMS AND LEGS AND THEN GOT GOOSE BUMPS, INCREASED SALIVATION, AND TACHYCARDIA WITH DESATURATION AND STARING WITH VARIABLE POSTICTAL PERIOD. THESE HAD BEEN INCREASING OVER THE PAST YEAR. THE PATIENT ALSO HAD NIGHTTIME MYOCLONIC STARTLES BUT HAD NOT HAD EVIDENCE OF ANY EPISODES AS SEIZURE ACTIVITY SEEN ON THE EEG ON THE DATE OF THE REPORT. THE PATIENT WAS ¿DEFINITELY NOT AT THE STAGE SHE WAS¿ BACK WHEN THE PUMP WAS INITIALLY PLACED. THE HEALTH CARE PROVIDER (HCP) FOUND IT ¿HARD TO IMAGINE¿ THAT IF THERE WAS A PROBLEM WITH THE PUMP IT WOULD HAPPEN IN A CYCLIC MANNER, BUT ALWAYS BE ABSENT DURING THE TIME THAT SHE WAS HOSPITALIZED GIVEN THE FACT THAT SHE HAD SOME FAIRLY PROLONGED HOSPITALIZATION. IT WAS NOT KNOWN IF WHAT THE PATIENT WAS EXPERIENCING WAS RELATED TO SEIZURE ACTIVITY. THE NEXT STEP WAS TO ADMIT THE PATIENT AND DO A ROTOR STUDY, AN INTRATHECAL DYE INJECTION, AND NUCLEAR MEDICINE STUDY ALL AT ONE TIME. THE ODDS OF THE EVENT BEING HER PUMP WERE CONSIDERED RELATIVELY LOW, BUT IT NEEDED TO BE DETERMINED. THE CAUSE OF THE EVENT WAS THOUGHT TO BE A SEDATIVE EFFECT OF ORAL MEDICATIONS WHICH WERE BEING WEANED, AND NOT THE PUMP. THE PATIENT¿S ORAL MEDICATIONS INCLUDED KLONAPIN, BACLOFEN, OXYBUTYNIN, MIRALAX, GABAPENTIN, CHOLECALCIFEROL, PEPCID MULTIVITAMINS, OXYTROL PATCH, CLOBETASOL, AND ZYPREXA. THE PATIENT WAS BEING MANAGED BY A HEALTH CARE PROVIDER. IT WAS BEING CONSIDERED TO JUST TAPER THE PATIENT OFF INTRATHECAL BACLOFEN GRADUALLY SO THAT SHE COULD NOT HAVE ANY POTENTIAL FOR OVERDOSE PHENOMENA AND INSTEAD REPLACING ALL THAT WITH ORAL BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428996 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization