BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4250573 · Received November 14, 2014

    Report

    Report Number
    3004209178-2014-21579
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Report Date
    October 23, 2014
    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
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT MISSED A REFILL AND THE LOW RESERVOIR ALARM OCCURRED ON (B)(6) 2014 AND WAS EMPTY ON (B)(6) 2014. AN ALARM WAS HEARD AND A CRITICAL ALARM WAS CONFIRMED BY TELEMETRY DUE TO ZERO ML RESERVOIR VOLUME REACHED. THE PATIENT¿S TONE HAD BEEN WORSE FOR TWO WEEKS AND THE PATIENT HAD BEEN ITCHING 4 DAYS. THE REPORTER STATED THAT THE PATIENT WAS ¿COMFORTABLE BUT TIGHT¿ IN THE CLINIC TODAY. THE PUMP WAS USED TO INFUSE BACLOFEN (UNKNOWN). NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THE PATIENT WAS LAST SEEN BY THE PREVIOUS PHYSICIAN ON (B)(6) 2014. THE PATIENT WAS SEEN BY THE NEW PHYSICIAN ON (B)(6) 2014. THE CAUSE OF THE ITCHING AND INCREASED TONE WAS INTRATHECAL BACLOFEN WITHDRAWAL SECONDARY TO EMPTY PUMP RESERVOIR. THE CRITICAL ALARM WAS SOUNDING FOR AN EMPTY PUMP DUE TO A MISSED REFILL. THE ALARM DATE WAS (B)(6) 2014 AND WAS CONFIRMED VIA TELEMETRY. THE PUMP HAD BEEN SOUNDING A CRITICAL ALARM FOR ABOUT ONE MONTH. NO TROUBLESHOOTING, INTERVENTIONS OR OTHER ACTIONS WERE TAKEN. PER THE PUMP LOGS, THE EMPTY RESERVOIR ALARM OCCURRED ON (B)(6) 2014. THE PUMP WAS REFILLED WITH GABLOFEN AND HIGH RESISTANCE WAS MET WHEN ATTEMPTING TO INJECT THE MEDICATION THE FIRST THREE TIMES. THE HCP WAS ABLE TO SUCCESSFULLY INSTILL THE MEDICINE ON THE FOURTH ATTEMPT. THE RATE WAS DECREASED BY 53% IN ORDER TO REINTRODUCE THE DRUG SLOWLY. DUE TO THE PROLONGED TIME WITHOUT THERAPY, THE PHYSICIAN RESTARTED THE DOSE AT 100MCG/DAY SIMPLE CONTINUOUS MODE TO DECREASE THE RISK OF OVERDOSE AND THE PATIENT WAS MONITORED FOR SIGNS OF OVERDOSE AS WELL AS CLINICAL RESPONSE OF IMPROVEMENT IN SPASTICITY. THE NEW LOW RESERVOIR ALARM DATE WAS (B)(6) 2015. DURING THE FOLLOW-UP VISIT ON (B)(6) 2014, THE PATIENT REPORTED THAT SHE HAD BETTER CONTROL AND MOBILITY OF THE LEFT LEG AND LEFT ARM. THE DOSE WAS INCREASED 25% MAKING THE NEW DAILY RATE 125 MCG/DAY IN SIMPLE CONTINUOUS MODE. THE NEW LOW RESERVOIR ALARM DATE WAS (B)(6) 2015. THE PATIENT WAS DOING WELL WITH THERAPY AT CURRENT DOSING AND WAS NO LONGER HAVING ANY ISSUES. THE PATIENT HAD RESOLUTION OF ALL WITHDRAWAL SYMPTOMS AND HER TONE RETURNED TO NEARLY BASELINE WITH RESUMING HER PRIOR DOSE. THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738671 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR