BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3190406 · Received June 26, 2013

    Report

    Report Number
    3004209178-2013-10895
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    May 13, 2013
    Report Date
    July 13, 2015
    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
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007. PRODUCT TYPE: CATHETER: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007. PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE HEALTH CARE PROVIDER (HCP) WAS UNSURE OF THE CAUSE OF THE EVENT. A DYE STUDY WAS PERFORMED ON (B)(6) 2013, CEREBROSPINAL FLUID WAS WITHDRAWN AND THE PRIMING BOLUS OF THE CATHETER WAS ONLY DONE OVER 12 MINUTES AND APPROXIMATELY 90 MINUTES LATER THE PATIENT HAD RESPIRATORY DISTRESS AND A CODE WAS CALLED. THE PUMP WAS AS REPORTED TURNED DOWN TO MINIMAL RATE. IT WAS NOTED AN X-RAY WAS PERFORMED HOWEVER THE TIMEFRAME WAS NOT PROVIDED. THE PATIENT EXPERIENCED WITHDRAWAL TYPE SYMPTOMS FOR APPROXIMATELY 4 WEEKS ¿PER PATIENT¿. THE PATIENT REQUIRED HOSPITALIZATION DUE TO THE EVENT AND EXPERIENCED INCREASED PAIN, SPASMS, NAUSEA AND FELT ILL. SURGICAL INTERVENTION HAD NOT OCCURRED BUT IT WAS NOTED IT WAS PLANNED FOR ¿THIS FALL¿. THE PATIENT OUTCOME WAS CONSIDERED SERIOUS LIFE THREATENING INJURY/ILLNESS AND THE PATIENT RECOVERED WITHOUT SEQUELAE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ¿IN FLUORO¿ FOR A DYE STUDY. 1.2 ML WAS REMOVED FROM THE CATHETER AND 8ML OF OMNIPAQUE 240PF (PYROGEN-FREE) WAS INJECTED. THE HEALTH CARE PROVIDER (HCP) WAS ¿UNABLE TO VISUALIZE OMNIPAQUE VIA FLUORO OR SUBSEQUENT CT¿. A PRIMING BOLUS WAS THEN PROGRAMMED OF 391.5MCG TO RUN IN OVER 12 MINUTES. THE PATIENT WAS ON 180MCG PER DAY AND ¿SUSPECTED¿ 2000MCG/ML. TWO HOURS AFTER THE OMNIPAQUE WAS INJECTED, THE PATIENT HAD CARDIAC ARREST. IT WAS REPORTED ¿LOW CERVICAL TIP PLACEMENT AND CERVICAL STENOSIS NOTED ON MD REPORT¿. AS A RESULT OF THE EVENT, THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU) AND MEDICAL INTERVENTION WAS REQUIRED HOWEVER ADDITIONAL DETAILS WERE UNKNOWN TO THE REPORTER. THE DEVICE SYSTEM WAS USED TO DELIVER GABLOFEN. IT WAS LATER REPORTED THE REPORTER HAD NOT YET SEEN THE PATIENT AND THAT THE PATIENT WAS ¿SEEING THIS TEAM AS A SECOND OPINION¿. NO FURTHER INFORMATION WAS AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT PRIOR TO TAKING THE PATIENT FOR A CT (COMPUTED TOMOGRAPHY) SCAN TO VISUALIZE THE DYE STUDY, THE PUMP WAS RESET BY THE HEALTHCARE PROFESSIONAL (HCP). THE PATIENT WAS VERY GROGGY DURING THE CT, AND "NEXT TIME I WOKE UP I WAS IN THE HOSPITAL ICU WITH IV'S AND CATHETERS." THE HCP TOLD THE PATIENT THAT THE PUMP RESET GAVE THE PATIENT AN OVERDOSE OF BACLOFEN. DUE TO CARDIAC ARREST, THE PATIENT SPENT FOUR DAYS IN THE HOSPITAL AND THE PUMP WAS SET TO "JUST A TRICKLE" BECAUSE THE PATIENT WAS TOO WEAK TO TAKE IT OUT. THE PATIENT REPORTEDLY WENT THROUGH SEVERE DRUG WITHDRAWAL, HAD CHEST PAINS AND "LIVED ON MY COUCH BASICALLY FOR THREE MONTHS AFTER THE INCIDENT." THE PATIENT HAD VERY HIGH ANXIETY, MUSCLE SPASMS, HAD "WORSE" HEART PALPITATIONS, AND SLEEP PROBLEMS. THE PATIENT MENTIONED THAT DUE TO AN INFLAMED STOMACH DURING A PREVIOUS ENDOSCOPY, THEY COULDN'T TAKE MANY OTHER MEDICATIONS FOR PAIN "BECAUSE MY STOMACH SINCE THEN CAN'T TOLERATE A LOT OF REGULAR TAKING OF MEDICINE." THE PATIENT STATED ALL OF HER HEALTH ISSUES GOT WORSE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT RECENTLY HAD ¿A MAJOR, MAJOR PROBLEM WITH THIS PUMP¿. THE PATIENT REPORTEDLY WAS GETTING ¿TOO MUCH AND THEN TOO LITTLE¿ MEDICATION WHICH RESULTED IN HOSPITALIZATION BECAUSE ¿I WAS SO SICK WITH THIS FOR MONTHS¿. THE PATIENT ENDED UP HAVING AN OVERDOSE FROM THE MEDICATION FROM THE DYE STUDY. IT WAS REPORTED, ¿THEY STATED THAT IT WAS THE PUMP ITSELF THAT HAD A PROBLEM BECAUSE THE PROCEDURES WERE CORRECT¿. THE PATIENT FELT THE PUMP WAS ¿STARTING UP AND STOPPING¿. THE PATIENT WENT THROUGH ¿LOTS OF TESTS¿ FOR EIGHT MONTHS BECAUSE ¿THEY DIDN¿T THINK IT WAS PUMP SO I WENT TO MY PRIMARY DOCTOR AND WENT TO GO THROUGH ALL THESE TESTS. AND EVERYTHING WAS FINE AND IT TURNS OUT A LOT OF THESE THINGS WERE THE PUMP BECAUSE I DON¿T HAVE THE SYMPTOMS RIGHT NOW¿. IT WAS REPORTED THE PROBLEMS BEGAN OCCURRED ¿SINCE LIKE (B)(6) LAST YEAR AND WHAT HAPPENED TO ME IN THE HOSPITAL WAS JUST IN (B)(6)¿. RELATED TO THE PATIENT FEELING THERE WAS ¿TOO MUCH¿ MEDICATION BEING DELIVERED FROM THE PUMP AT TIMES IT WAS STATED ¿AND THEN I WOULD GO THROUGH LIKE SEVERE WITHDRAWAL SYMPTOMS AND THEN I WOULD GO THROUGH LIKE I HAD TOO MUCH IN MY SYSTEM¿. IT WAS NOTED THE PATIENT ENDED UP HAVING CPR IN THE HOSPITAL. THE PATIENT HAD AN APPOINTMENT WITH THEIR HEALTH CARE PROVIDER ON THE DAY OF THIS REPORT. IT WAS LATER REPORTED THAT THE PATIENT HAD A CHANGE IN THERAPY EFFECT. THE PATIENT REPORTEDLY HAD PROBLEMS WITH THEIR PUMP SINCE (B)(6) 2012. THE PATIENT HAD A LOT OF SPASTICITY ¿LIKE SHE HAS TOO MUCH OR TOO LITTLE MEDICATION¿ THAT THE SPASTICITY RELIEF WAS SPORADIC. THE DYE STUDY, AS PREVIOUSLY REPORTED, THAT OCCURRED ON (B)(6) 2013 RESULTED IN THE HEALTH CARE PROVIDER (HCP) NOT BEING ABLE TO GET DYE THROUGH THE CATHETER. FOLLOWING THE DYE STUDY THE HCP REPORTEDLY RESTARTED THE PATIENT¿S PUMP AND SENT HER FOR A CT SCAN. THE PUMP REPORTEDLY GAVE THE PATIENT AN EXTRA BOLUS, WHICH CAUSED THE OVERDOSE. THE HCP IN TURN ¿SHUT DOWN THE PUMP¿ AND SET IT TO MINIMUM RATE. AS A RESULT, THE PATIENT WENT THROUGH BACLOFEN WITHDRAWAL. THE PUMP WAS EVENTUALLY FILLED WITH SALINE. THE PATIENT WAS PUT ON ORAL MEDICATION BUT WAS NOT TAKING ANYTHING FOR SPASTICITY. IT WAS NOTED THE PATIENT NO LONGER FELT THE ¿FLUSHING AND BURNING SENSATION¿ THROUGHOUT HER BODY AS WHEN SHE HAD MEDICATION IN HER PUMP. THE PATIENT ALSO NO LONGER FELT THE ¿BRAIN FOG¿ AND WAS ABLE TO CONCENTRATE BETTER. IT WAS NOTED THE PATIENT WAS ON HYDROCODONE, TOPAMAX, CYCLOBENZAPRINE AS NEEDED ALTHOUGH IT WAS NOTED H ER HEART RATE INCREASED WITH IT. THE PATIENT WAS ALSO ON ARTHROTEC, LORAZEPAM FOR ANXIETY AND CITALOPRAM BUT WAS GOING OFF OF IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289813 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Hospitalization| L| R