BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3200879 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-11155
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    June 6, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709SC LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) IS NOT APPLICABLE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT OVER THE LAST YEAR, THE PATIENT HAS HAD EPISODES WHERE SHE ENDS UP IN THE ER WITH DECREASED AROUSAL AND REQUIRES INTUBATION. OTHER PRESCRIPTION (XANAX) AND NON-PRESCRIPTION DRUGS ((B)(6)) HAVE BEEN FOUND IN HER SYSTEM ON PRIOR ADMISSIONS. IT WAS UNKNOWN IF THOSE WERE CONTRIBUTING TO THE SITUATION. THE PATIENT HAS ALSO CALLED AT OTHER TIMES REQUESTING AN INCREASE DUE TO INCREASED SPASTICITY. A SINGLE BOLUS WAS PROGRAMMED AT ONE POINT AND THE SPASTICITY WAS RELIEVED AFTER THE BOLUS WHICH MADE HEALTH CARE TEAM FEEL THAT THE CATHETER WAS LIKELY INTACT. MOST RECENTLY, THE PATIENT CALLED TO REQUEST AN INCREASE IN DOSE DUE TO SPASTICITY. WHEN THE HEALTH CARE PROFESSIONAL RETURNED THE CALL TO THE PATIENT, SHE LEARNED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH DECREASED TEMP, DECREASED BLOOD PRESSURE AND DECREASED AROUSAL. SHE WAS ADMITTED AND INTUBATED. IT WAS NOTED THAT THE PATIENT ALSO HAD A UTI ON ADMISSION. THE LEVEL OF SPASTICITY WAS NOT DOCUMENTED IN THE HOSPITAL NOTES. THE PATIENT SYMPTOMS WERE AN ALTERED MENTAL STATUS, OVERDOSE SYMPTOMS OF DECREASED AROUSAL AND DECREASED BLOOD PRESSURE AND OTHER GENERALIZED SYMPTOMS. TROUBLE SHOOTING WAS BEING CONSIDERED. A DYE STUDY WAS TO BE SCHEDULED. THE PATIENT OUTCOME WAS ¿ALIVE ¿ WITH INJURY¿. THE DEVICE SYSTEM WAS USED TO DELIVER GABLOFEN. IT WAS LATER REPORTED THAT THE PATIENT HAD EXPERIENCED ON AND OFF SPASTICITY, SOME OVERDOSE SYMPTOMS (SLEEPINESS), OVER THE PAST SEVERAL MONTHS AND SPANNING MULTIPLE REFILLS. IT WAS NOTED THAT THE "PATIENT TENDS TO SELF-MEDICATE" AND IS ON A "LOT OF OTHER MEDS" IN ADDITION TO THE BACLOFEN IN THE PUMP. PER THE REPORTER, A DYE STUDY IS BEING DONE IN AN ATTEMPT TO RULE OUT THE PUMP OR CATHETER AS THE SOURCE OF THE ISSUES.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT A REVISION WAS PERFORMED ON (B)(6) 2013. A DYE STUDY HAD BEEN ATTEMPTED PRIOR TO THE SURGERY AND NOTHING WAS ABLE TO BE ASPIRATED. THE SURGEON FOUND THE PATIENT TO HAVE SEVERE SPINAL STENOSIS AND INDICATED THAT THE BONE HAD GROWN AND WAS COMPRESSING THE CATHETER. A DECOMPRESSION/LAMINECTOMY WAS PERFORMED AND THE CATHETER WAS FREED. IT WAS NOTED THAT THE CATHETER FLOWED FREELY. AN INTRAOPERATIVE DYE STUDY WAS PERFORMED AND NO LEAKS OR TEARS WERE FOUND. THE CATHETER WASN'T REVISED OR REPLACED EXCEPT A NEW SUTURELESS CONNECTOR WAS USED EVEN THOUGH NO DAMAGE WAS NOTED. IT WAS DECIDED TO REPLACE THE PUMP AT THE SAME TIME BECAUSE THE ERI WAS 12 MONTHS AND THEY ALREADY ¿HAD THE PATIENT OPEN¿ FOR THE CATHETER REVISION. PER THE REPORTER, THERE WAS "GOOD FLOW" POST REVISION.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT A SURGICAL REVISION WAS DONE ON (B)(6) 2013 BECAUSE THE CATHETER HAD BEEN PINCHED BY A BONE GROWTH FROM THE PATIENT¿S SPINE. IT WAS REPORTED THAT, BECAUSE OF THE PINCHED CATHETER, THE DRUG WAS ¿FORCED THROUGH¿ AND WAS OVERDOSING THE PATIENT. THE PATIENT WENT THROUGH THAT FOR TWO YEARS. A MYELOGRAM WAS DONE TO TEST THE PUMP AND FOUND THAT THE CATHETER WAS PINCHED/BLOCKED. THE MYELOGRAM WAS UNSUCCESSFUL BECAUSE THE HCP COULD NOT INJECT DYE IN BECAUSE THE ¿TEST PORT¿ WOULD NOT ALLOW ASPIRATION. THE PATIENT HAD SPASMS ¿REAL BAD¿ BECAUSE OF THE PINCHED ISSUE. THEN IT WOULD OVERDOSE HER AND SHE WOULD BE FOUND UNCONSCIOUS, SENT TO THE HOSPITAL, AND THE PATIENT WAS TOLD SHE TRIED TO COMMIT SUICIDE OR WAS TAKING TOO MANY PILLS. THE PATIENT'S ¿LEGS HAD BEEN ACTING UP SO BAD.¿ IT WAS LATER REPORTED THAT A CATHETER KINK OCCURRED. IT WAS PINCHED BETWEEN THE SUPERIOR AND INFERIOR LUMBAR LAMINA. THE PATIENT WOULD BE INADEQUATELY TREATED WITH MEDICATION AND THEN SUDDENLY EXPERIENCE AN OVERDOSE. AN X-RAY WAS DONE, HOWEVER THE RESULTS WERE NOT REPORTED. THE PATIENT RECOVERED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303236 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR Hospitalization| R