BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3241238 · Received July 22, 2013

    Report

    Report Number
    3004209178-2013-12111
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Report Date
    June 27, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: CATHETER. PRODUCT ID: 8840, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD INCREASED SPASTICITY. THE HEALTHCARE PROVIDER (HCP) PERFORMED A CATHETER DYE STUDY AND NOTED THE CATHETER WAS PATENT. THE HCP ALSO NOTED THAT THERE WAS NO VOLUME DISCREPANCY. THE HCP ¿FELT THE PUMP WAS DOING FINE.¿ DUE TO THE SYMPTOMS, THE HCP DECIDED TO CHANGE THE MEDICATION FROM COMPOUNDED BACLOFEN 1100MCG/ML TO LIORESAL 500MCG/ML. THE PATIENT HAD BEEN RECEIVING 150MCG/DAY ON SIMPLE CONTINUOUS MODE. THE HCP PERFORMED A PRIMING BOLUS OF THE CATHETER VOLUME AND THE INTERNAL PUMP TUBING. THE HCP THEN CONSULTED THE REPORTER WHO QUESTIONED THE PRIMING BOLUS AND DISCUSSED THAT A BRIDGE BOLUS SHOULD HAVE BEEN PERFORMED INSTEAD. THE PATIENT WAS SENT HOME AND IT WAS CALCULATED THAT THE PATIENT WAS TO RECEIVE A BOLUS OF 218 OR 219MCG. THE HCP WAS TO CALL THE PATIENT AT HOME AND HAVE THEM RETURN TO THE CLINIC TO PERFORM THE BRIDGE BOLUS CORRECTLY; HOWEVER, THE CALLER WAS CONCERNED AS THE PATIENT SHOULD HAVE ALREADY RECEIVED THE ENTIRE BOLUS. THE REPORTER WAS TO DISCUSS POSSIBLE OPTIONS WITH THE HCP. IT WAS LATER REPORTED THAT THE LIORESAL WAS PUT IN THE PUMP TO REPLACE COMPOUNDED BACLOFEN THAT THE PATIENT REPORTED WAS INEFFECTIVE. PER THE HCP, THE PATIENT WAS DOING MUCH BETTER FOLLOWING THE CHANGE. THE PATIENT WAS RECEIVING EFFECTIVE THERAPY. IT WAS LATER REPORTED THAT THE PATIENT WAS HAVING ¿NECK ISSUES.¿ THE HCP DID A CERVICAL CT AND WANTED TO DO A CERVICAL MRI. THE PATIENT NOTED THAT HE HAD A NEW HCP. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341349 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1