BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4102147 · Received September 19, 2014

    Report

    Report Number
    3004209178-2014-17379
    Event Type
    Injury
    Date Received
    September 19, 2014
    Report Date
    August 26, 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
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, LOT # N175906008, IMPLANTED: (B)(6) 2008, PRODUCT TYPE CATHETER; PRODUCT ID 8709SC, LOT # N175906008, IMPLANTED: (B)(6) 2008, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CHANGE IN THERAPY EFFECT OCCURRED; THE PATIENT¿S SYMPTOMS RETURNED. THE SYMPTOMS STARTED BACK IN (B)(6) 2014. WITHDRAWAL WAS REPORTED. EPISODIC MYOCLONUS WAS ALSO NOTED. THE FIRST THREE TIMES WAS WHEN THE PATIENT WAS WITH HER DAD AND THE REPORTER DIDN¿T KNOW IF IT WAS SUDDEN OR A GRADUAL ONSET. THE PATIENT DID HAVE ONE WITH THE REPORTER AND IT WAS REPORTED IT STARTED AND STAYED UNTIL THE PATIENT HAD MEDICINE WHICH HELPED CALM DOWN THE SYMPTOMS. THE REPORTER DIDN¿T KNOW WHAT WAS GOING ON AND WHAT HELPED OR IF IT RUNS ITS COURSE. THE PATIENT¿S SPASMS ¿HAVE BEEN VERY LITTLE ONE DAY BEGINNING OF (B)(6)¿ AND THE PATIENT WAS BACK WITH SPASMS THAT THEY COULDN¿T CONTROL, THEY WERE DROOLING AND OUT OF IT. THE PATIENT ENDED UP IN THE ER (EMERGENCY ROOM) AND WAS GIVEN ORAL BACLOFEN. THE PATIENT THEN FELL ASLEEP AND CALMED DOWN AND WOKE UP OKAY. THERE HAD BEEN NO ISSUES WITH REFILLS. NO ONE HAD SAID ANYTHING IN REGARDS TO ANY ISSUES WITH REFILLS AND THE PATIENT HAD ONLY HAD ONE REFILL SINCE THIS HAD STARTED. IT HAPPENED AGAIN AT THE END OF JUNE WITH SIMILAR SYMPTOMS AS IN (B)(6) AND THE PATIENT WENT BACK TO THE ER. THE PATIENT WAS GIVEN ORAL BACLOFEN AGAIN AND TYLENOL FOR A FEVER OF 104 DEGREES AS WELL AS A PAIN RELIEVER. IT HAD HAPPENED TWO MORE TIMES FOLLOWING THAT, ONE IN (B)(6) 2014 AND THE OTHER IN (B)(6) 2014. THE PATIENT WAS ¿TAKEN TO THE ER HOSPITAL¿ BECAUSE THEY ¿HAD AN ORAL BACLOFEN PRESCRIPTION AT HOME TO USE¿ THAT WAS PRESCRIBED BY THE HCP. IT WAS THEN NOTED THE FIRST EPISODE, IN (B)(6) 2014, THE PATIENT WAS WITH HER DAD AND HAD TO HAVE 3 DOSES OF ORAL BACLOFEN TO RELIEVE SYMPTOMS. THE ONE IN AUGUST, THE REPORTER GAVE THE PATIENT ONE DOSE OF ORAL BACLOFEN AND DIASTAT INJECTION FOR SEIZURES TO CALM THE PATIENT DOWN AND TO HELP HER SLEEP. THE PATIENT WOKE UP AFTER THAT AND WAS FINE. THE FIRST TWO WITHDRAWAL TIMES, THEY DID LABS AND X-RAYS AND EVERYTHING WAS FOUND TO BE NORMAL. THE REPORTER DIDN¿T THINK A DYE STUDY HAD BEEN DONE ¿BECAUSE IT PROBABLY ISN¿T GOING TO ANSWER THE ISSUE ALL THE TIME¿ AND THE HEALTH CARE PROVIDER (HCP) REPORTEDLY ¿THINKS THE CATHETER IS KINKING INTERMITTENTLY AND A DYE STUDY MAY SHOW THAT EVERYTHING IS FINE WHEN EVERYTHING MIGHT NOT BE.¿ THE CAUSE OF THE EVENT REMAINED UNKNOWN HOWEVER THE HCP ATTRIBUTED THE EVENT TO THE CATHETER BUT THE CATHETER ISSUE WAS ALSO NOTED TO BE UNKNOWN. IT WAS REPORTED THEY WERE ¿HAVING A LOT OF PROBLEMS¿ WITH WITHDRAWAL WITH THE CATHETER KINKING. IT WAS ALSO NOTED THE PATIENT WAS EXPERIENCING THE WITHDRAWAL FROM ¿LACK OF DELIVERY.¿ THE PUMP HAD BEEN INTERROGATED AND REVEALED NO PUMP ERRORS. THE PATIENT WAS JUST AT THE HCP¿S THE WEEK PRIOR TO THE DATE OF THIS REPORT AND WAS SUPPOSED TO GET THE CATHETER AND PUMP REPLACED BUT IT DIDN¿T HAPPEN. IT HAD TO BE RESCHEDULED DUE TO MISCOMMUNICATION. THE PATIENT¿S OUTCOME WAS UNKNOWN TO THE HCP. THE DEVICE SYSTEM WAS USED TO DELIVER LIORESAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584984 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00012 YR Required Intervention