BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3040637 · Received April 8, 2013

    Report

    Report Number
    3004209178-2013-04855
    Event Type
    Injury
    Date Received
    April 8, 2013
    Report Date
    March 10, 2013
    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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8840, SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN; PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MANUFACTURER REPRESENTATIVE RECEIVED INFORMATION FROM A PHYSICIAN TRYING TO CONFIRM DRUG CONCENTRATION FOR A PATIENT. THE PATIENT WAS BROUGHT TO THE EMERGENCY ROOM (ER) FOR RESPIRATORY DEPRESSION WHICH WAS DETERMINED TO BE A RESULT OF BACLOFEN OVERDOSE. THE REPRESENTATIVE WAS INFORMED THAT THE PATIENT WAS DOING FINE AND WAS NO LONGER EXPERIENCING RESPIRATORY ISSUES. IT WAS NOT CONFIRMED WHAT TYPE OF BACLOFEN WAS USED WITH THIS PATIENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT'S FAMILY THAT THE PATIENT HAD HIS FIRST PUMP IMPLANTED IN (B)(6) 2013. THE PATIENT'S MOTHER REPORTED THAT 'IT WORKED OKAY IN THE VERY BEGINNING, BUT NOW A COUPLE OF MONTHS LATER WE DON'T REALLY SEE THAT IT IS DOING MUCH GOOD.' ON (B)(6) 2012, A NURSE PERFORMED A REFILL AND INJECTED THE INCORRECT CONCENTRATION. THE PATIENT WAS TO RECEIVE 500 MCG OF BACLOFEN AND WAS ACCIDENTALLY GIVEN 2000 MCG INSTEAD. ACCORDING TO THE PATIENT'S MOTHER 'BECAUSE THE NURSE DIDN'T KNOW THAT THE CONCENTRATION THEY PUT IN THERE DURING SURGERY WAS 500, SO SHE ACCIDENTALLY ASSUMED IT WAS THE SAME. BUT SHE ENDED UP PUTTING IN 2000 VERSUS 500.' ON (B)(6) 2013, THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO AN OVERDOSE. THE PATIENT'S MOTHER REPORTED THAT 'THEY GOT THE OVERDOSE TAKEN CARE OF, ALL CLEARED UP OUT OF HIS SYSTEM OVER SEVERAL DAYS.' AT THE TIME OF THIS REPORT THE PATIENT WAS STILL HOSPITALIZED. THE HEALTH CARE PROVIDERS LEFT THE INCORRECT CONCENTRATION OF BACLOFEN IN THE PUMP AND REPROGRAMMED THE PUMP ACCORDINGLY. SINCE THE INCORRECT CONCENTRATION WAS ADDED TO THE PUMP, THEY HAVE BEEN UNABLE TO GET THE PATIENT'S DYSTONIA UNDER CONTROL AND 'CAN'T FIGURE OUT WHY.' RECENTLY THE PHYSICIAN PERFORMED AN X-RAY OF THE PUMP AND TUBING WHICH SHOWED NO PROBLEMS. ON (B)(6) 2013, A DYE TEST WAS PERFORMED OF THE CATHETER AND NO PROBLEMS WITH KINKS OR LEAKS WERE FOUND. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142571 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R