BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3474668 · Received November 18, 2013

    Report

    Report Number
    3004209178-2013-20982
    Event Type
    Injury
    Date Received
    November 18, 2013
    Report Date
    February 12, 2019
    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
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8711, SERIAL # (B)(4), PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PUMP BECAME EMPTY BEFORE A REFILL AND ADMINISTRATION DISCONTINUED, LEADING TO A FEVER AND ELEVATED CPK NOTED AS WITHDRAWAL SYMPTOMS. THE PATIENT DEVELOPED A FEVER ON (B)(6) 2013 AND AN ELEVATED CREATINE PHOSPHOKINASE (CPK) ON (B)(6) 2013. THE PATIENT WAS HOSPITALIZED. THE CPK INCREASED TO ALMOST 17,000. THE REMAINING DRUG LEVEL WAS ZERO (0) ON THE PROGRAMMER DISPLAY DURING A REFILL. AS A VERY SMALL AMOUNT OF REMAINING DRUG COULD BE DRAWN, 18 ML OF GABALON 2000 UG/ML WAS REFILLED. THE CPK DECREASED TO 2,600 ONCE THE REFILLED DRUG WAS DELIVERED FROM THE PUMP WHICH HAD BEEN EMPTY. THE OUTCOME WAS NOTED AS NOT RECOVERED. IT WAS INDICATED IT WAS RELATED TO THE DRUG AND THE PROCEDURE. THE EVENT WAS AN INCORRECT REFILL INTERVAL, AND THERE WERE NO PROBLEMS WITH THE DRUG AND THE DEVICE. ON (B)(6) 2013, IT WAS CONSIDERED THAT THE PATIENT'S CONDITION STABILIZED. THE PUMP WAS DELIVERING GABALON.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT'S NEXT REFILL DATE WAS SCHEDULED AND MUST HAVE BEEN SCHEDULED DEPENDING ON THE DOSAGE OF THE PATIENT. FOR THIS PATIENT, AN EMPTY PUMP RESERVOIR OCCURRED BEFORE THE SCHEDULED REFILL DATE AND THIS RESULTED IN WITHDRAWAL SYMPTOMS. REPORTEDLY, THE PERSON WHO READ THE PROGRAMMER VALUES WAS DIFFERENT FROM THE PERSON WHO ENTERED THE INFORMATION INTO THE PATIENT'S MEDICAL RECORD AND THIS MAY HAVE RESULTED IN THE INCORRECT ENTRY OF DATE. THE PATIENT'S STATUS WAS NOW REPORTED AS RECOVERED. SHOULD ADDITIONAL INFORMATION BE RECEIVED A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT A REFILL WAS PERFORMED ON (B)(6) 2013 AT 12:00 BUT THERE WAS ONLY A VERY SMALL AMOUNT (AROUND 0.1ML) OF THE DRUG SOLUTION REMAINING IN THE PUMP. AS SUCH, THERE WAS NO DRUG (BACLOFEN) IN THE CATHETER AND THE PATIENT RETURNED HOME WITH NO SYMPTOMS, HOWEVER, THE SYMPTOMS APPEARED IN THE EVENING OF THAT DAY (WITHDRAWAL SYMPTOMS). WITHDRAWAL SYMPTOMS CONTINUED FROM THE EVENING OF (B)(6) 2013 UNTIL (B)(6) 2013 BUT A REFILL WAS PERFORMED ON THE 22ND WITH TREATMENT SO BACLOFEN ARRIVED AT THE INTRATHECAL SITE ONCE AGAIN AND SYMPTOMS IMPROVED. MUSCLE TIGHTNESS IMPROVED WHEN THE PATIENT WAS TRANSPORTED TO "YOUR" FACILITY ON (B)(6) 2013 AT 13:00. ALTHOUGH CK VALUES REMAINED ELEVATED, THESE WERE CONSIDERED TO HAVE BEEN ABNORMAL LABORATORY VALUES ASSOCIATED WITH WITHDRAWAL SYMPTOMS, SUCH AS MUSCLE TIGHTNESS, UP TO THE PREVIOUS DAY. BASED ON THIS COURSE, THE CAUSE OF THIS PATIENT'S SYMPTOMS WAS CONSIDERED TO HAVE BEEN THE REFILL BEING OVERDUE. PRIOR TO ITB THERAPY THE PATIENT COULD INGEST UP TO PILL (SLOW SWALLOWING) AS WELL AS PRIOR TO THE ONSET OF THIS ADVERSE EVENT. THE STATUS OF THE ORAL INGESTION WAS REPORTED AS "NO CHANGE" PRIOR TO THE ONSET OF THE ADVERSE EVENT. PRIOR TO THE ITB THERAPY THE PATIENT WAS BEDRIDDEN AND COULD NOT SHIFT SLEEPING POSITIONS UNAIDED. IT WAS ALSO REPORTED THAT THE PATIENT "ALREADY HAD COMPLICATIONS OF ASPIRATION PNEUMONIA WHEN BROUGHT IN." IT WAS FURTHER CLARIFIED THAT THE ASPIRATION PNEUMONIA WAS CONSIDERED TO BE RELATED TO THIS EVENT OF WITHDRAWAL SYMPTOMS DUE TO THERE BEING NO DRUG SOLUTION IN THE PUMP.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A FOREIGN HEALTHCARE PROVIDER (HCP) VIA A CONFERENCE PRESENTATION AND VIA A BUSINESS PARTNER. IT WAS REPORTED THE PATIENT HAD ATHETOID CEREBRAL PALSY. IT WAS REPORTED ON (B)(6), A REFILL WAS PERFORMED AT THE DOSE OF 370 MCG/DAY. IT WAS THEN STATED THE PATIENT FORGOT AN APPOINTMENT, AND VISITED THE HOSPITAL ABOUT 2 WEEKS BEHIND SCHEDULE. ON (B)(6), IT SEEMED THAT AN ALARM RANG. ON (B)(6), IT SEEMED THERE WAS NO DRUG LEFT. ON (B)(6), A REFILL WAS PERFORMED AT THE DOSE OF 370 MCG/DAY. NO PARTICULAR CLINICAL CHANGE WAS OBSERVED. THE REMAINING VOLUME OF THE DRUG WAS INDICATED TO BE 0 ON THE PROGRAMMER. THE ACTUAL REMAINING VOLUME OF DRUG COULD ONLY BE ASPIRATED SLIGHTLY. ON (B)(6), EXACERBATION OF SPASTICITY AND VOMITING WERE DEVELOPED FROM THE EVENING, AND THE PATIENT COULD NOT TAKE MEALS. ON (B)(6), THE PATIENT HAD A FEVER OF 39 DEGREES, AND VISITED THE HOSPITAL FROM THE FACILITY. THE PATIENT RECEIVED AN INTRAVENOUS INJECTION OF DANTRIUM. AFTER THAT, SWEATING WAS OBVIOUS AND VOLUME OF URINE WAS REDUCED. ON (B)(6), DORMICUM WAS USED. AFTER THAT, AN INCREASE IN CREATINE KINASE (CK) WAS OBSERVED, SO THAT THE PATIENT WAS TRANSFERRED EMERGENTLY. AFTER TRANSFER, OPERABILITY OF THE PUMP WAS CHECKED AND NO PROBLEM IN THE CATHETER WAS DETECTED. CK WAS 13495MG/DL ON (B)(6). NEUROLEPTIC MALIGNANT SYNDROME DUE TO INTERRUPTION OF GABALON WAS DIAGNOSED. HYDRATION AND GENERAL CARE WERE PERFORMED. AFTER THAT, THE SYMPTOMS WERE IMPROVED. ON (B)(6), THE PATIENT WAS TRANSFERRED TO THE ORIGINAL HOSPITAL. FURTHER COMPLICATIONS WERE NOT REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595451 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00026 YR Hospitalization