BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4201981 · Received October 27, 2014

    Report

    Report Number
    3004209178-2014-20394
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    October 3, 2014
    Report Date
    October 3, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1060-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8578, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: ACCESSORY; PRODUCT ID 8731, LOT# B005799N04, IMPLANTED: (B)(6) 2003, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT ALSO EXPERIENCED HYPOXIA AND LETHARGY. IT WAS ALSO NOTED THAT THE PATIENT WAS TAKING AMLODIPINE AT THE TIME OF THE EVENT.

    Description of Event or Problem · 1

    THE PATIENT HAD A HISTORY OF A STROKE PRIOR TO THE PUMP BEING IMPLANTED. THE PATIENT WAS RECEIVING INTRATHECAL BACLOFEN THERAPY FOR THE SPASTICITY CAUSED BY THE STROKE. ON THE DATE OF THIS REPORT, THE PUMP WAS REFILLED AT 8:15AM WITH 40CC OF LIORESAL (2000 MCG/ML). WITHIN 30 MINUTES OF THE REFILL, THE PATIENT WAS SYMPTOMATIC; MAINLY DIZZY AND SLURRING SPEECH. BY 8:45 HE WAS OBTUNDED AND INTUBATED ¿ ¿THEY TRIED A STERNAL RUB AND PUPILS WERE PIN POINT". THE PATIENT WAS HAVING A BACLOFEN OVERDOSE. THE NURSE THEN TRIED TO REMOVE THE DRUG TO SEE IF IT WAS IN THE POCKET. THE NURSE GOT BACK 40ML, BUT IT WAS BLOODY IN THE SYRINGE. THE NURSE PUT THE 40 ML BACK IN THE PUMP. AFTER THAT, 20ML WAS PULLED FROM THE PUMP POCKET. THE PUMP POCKET WAS DESCRIBED AS "BOGGY". THE PUMP WAS ACCESSED AGAIN BETWEEN 12:15-1PM AND THEY GOT 12 ML FROM THE PUMP; IT WAS CLEAR EXCEPT FOR ONE PIECE OF BLOOD FLOATING. ANOTHER HCP (HEALTHCARE PROFESSIONAL) ASSESSED THE NEEDLE POSITION AND THEN FILLED THE PUMP WITH A FRESH 40 ML. THEY PULLED 20 OUT AND THEN 11 MORE, SO APPROXIMATELY 31 WAS PULLED OUT OF THE POCKET. THE PATIENT WAS IN A COMA. THEY WERE SEEING ¿NO ELECTRICAL ACTIVITY¿/THE PATIENT CODED; THEY USED MEDICATION TO ¿START HIM¿. THE PATIENT¿S TEMPERATURE WAS 91 DEGREES FAHRENHEIT; THEY HAD A WARMING BLANKET ON THE PATIENT. THE PATIENT ALSO HAD A SEIZURE THE DATE OF THE EVENT. THE MEDICAL STAFF STATED THERE WAS SOME KIND OF ¿PAM¿ ON BOARD. THEY OPTED NOT TO DECREASE THE PUMP DOSE AT THE TIME OF THE EVENT AS THE PATIENT WAS BEING SUPPORTED, SO THE PUMP WAS STILL PROGRAMMED TO 300 MCG/DAY. THE PUMP LOGS WERE CHECKED AND THERE WAS NOTHING ABNORMAL IN THE LOGS. A CT OF THE ABDOMEN WAS DONE TO RULE OUT A CATHETER ISSUE, NONE WAS FOUND; THE CATHETER WAS NOT IN FRONT OF THE PUMP; THE ¿LENGTH OF THE CATHETER SEEMED INTERMITTENT¿; IT WOULD BE ¿VISIBLE, THEN NOT, THEN VISIBLE AGAIN¿. THE PATIENT¿S URINE SAMPLE WAS BLOODY; IT WAS NOTED THAT IT WAS HARD TO CATHETERIZE THE PATIENT. ON (B)(6) 2014, THEY DECREASED THE PUMP DOSE FROM 300 MCG/DAY TO 100 MCG/DAY AND WERE GOING TO MONITOR FOR UNDER DOSE SYMPTOMS AND ASSESS SPASTICITY. THE PATIENT WAS IN THE ICU (INTENSIVE CARE UNIT). THE ICU DOCTOR THOUGHT THAT THE PATIENT WAS GOING INTO NEUROGENIC SHOCK. THE PATIENT HAD HYPOTENSION AND BREATHING ISSUES. AS OF (B)(6) 2014, IT WAS DETERMINED THAT THE PATIENT ALSO HAD PNEUMONIA. THE PATIENT WAS A STROKE PATIENT AND HE HAD ONLY ONE SIDE AFFECTED WITH SPASTICITY. HIS UNAFFECTED SIDE WAS NORMAL AND THE SPASTIC SIDE WAS LOOSE. THE PATIENT WAS RESPONDING AND FOLLOWING SIMPLE COMMANDS AND THEY WERE HOPING TO EXTUBATE HIM THE NEXT DAY. ON (B)(6) 2014, IT WAS REPORTED THAT AN EEG WAS DONE AND THE PATIENT WAS FOUND TO HAVE TOXIC METABOLIC ENCEPHALOPATHY. IT WAS LATER REPORTED THAT THE PHYSICIANS AT THE HOSPITAL DID NOT AGREE ON THE INTERPRETATION OF THE EEG. ONE DOCTOR DIAGNOSED ACUTE METABOLIC ENCEPHALOPATHY; THE OTHER DOCTORS STATED IT WAS NOT POSSIBLE TO DIAGNOSE JUST FROM EEG RESULTS. AS OF (B)(6) 2014, THE PATIENT WAS EXTUBATED AND EATING; HE WAS NOTED TO BE ¿A LITTLE CONFUSED¿. AS OF (B)(6) 2014, THE PATIENT WAS BEING TRANSFERRED TO ANOTHER UNIT. THE PATIENT HAD MOMENTS OF CONFUSION. ON (B)(6) 2014, IT WAS REPORTED THAT THE PATIENT WAS NOT TAKING ANY ORAL MEDICATIONS. THE CAUSE OF THE EVENT WAS DETERMINED TO BE THAT THE NURSE FILLED THE POCKET WITH 40ML. THEY DID NOT KNOW HOW, AS SHE HAD BEEN FILLING PUMPS FOR 5 YEARS WITH NO ISSUE. IT WAS UNKNOWN IF A TEMPLATE WAS USED FOR THE REFILL OR NOT. THE PUMP WAS NOT FLIPPED OR MALPOSITIONED AND THERE WERE NO CATHETER ISSUES. THE NURSE STATED THAT SHE DID NOT KNOW IF THE MEDICATION WAS EVER REALLY IN THE PUMP, SHE COULD NOT TELL. THE PHYSICIAN BELIEVED THAT THE NURSE FILLED THE POCKET TWICE. THE PATIENT WAS DISCHARGED AFTER RETURNING TO BASELINE WITH NO FURTHER ISSUES. THE PATIENT WAS DOING WELL AND WAS RECEIVING EFFECTIVE THERAPY. THE CLINIC WAS PLANNING TO DO TRAINING WITH THEIR STAFF INCLUDING YEARLY COMPETENCY TRAINING FOR INTRATHECAL BACLOFEN PUMPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683281 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