BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3910188 · Received July 2, 2014

    Report

    Report Number
    3004209178-2014-12455
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    May 6, 2014
    Report Date
    September 20, 2016
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1060-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8711, LOT# N157280001, IMPLANTED: 2008 (B)(6); PRODUCT TYPE CATHETER PRODUCT ID 8590-1, LOT# N165213, IMPLANTED: 2008 (B)(6); PRODUCT TYPE ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: CONCLUSION CODE NO LONGER APPLICABLE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO THE PUMP REFILL THE PUMP WAS DELIVERING FENTANYL (2500 MCG/ML AT 749.2 MCG/DAY), BACLOFEN (170 MCG/ML AT 50.94 MCG/DAY), AND PRIALT (3 MCG/ML AT 0.8990 MCG/DAY). AT THE REFILL, THE BACLOFEN CONCENTRATION AND DOSE WERE CHANGED TO 135.0 MCG/ML AND 40.46 MCG/DAY; THE FENTANYL AND PRIALT CONCENTRATIONS AND DOSES REMAINED THE SAME. A SINGLE BOLUS DOSE WAS PROGRAMED TO DELIVER 50 MCG OF FENTANYL, 2.70 MCG OF BACLOFEN, AND 0.0600 MCG OF PRIALT OVER 5 MINUTES. THE PATIENT WAS FOUND UNCONSCIOUS IN THE CLINIC RESTROOM AFTER THE PUMP REFILL PROCEDURE. CPR (CARDIOPULMONARY RESUSCITATION) WAS STARTED AND OXYGEN WAS ADMINISTERED WHILE THE EMT (EMERGENCY MEDICAL TECHNICIAN) WAS NOTIFIED TO COME TO THE SITE. INTERVENTIONS ON (B)(6) 2014 INCLUDED 0.4 NARCAN; 0.1 NARCAN DRIP PER HOUR; AND 3 SETS OF TROPONINS. DIAGNOSTICS ON (B)(6) /2014 INCLUDED A SYNCOPE WORKUP WHICH RESULTED IN THE PATIENT BE ING HELD OVERNIGHT FOR OBSERVATION AND A CAROTID ULTRASOUND WHICH SHOWED ¿50% TO 79% LESION IN THE LEFT ICA (INTERNAL CAROTID ARTERY)¿. THE PATIENT STAYED OVERNIGHT IN THE HOSPITAL FOR OBSERVATION AND WAS INSTRUCTED TO BE SEEN BY A CARDIOLOGIST FOR FURTHER WORKUP. THE PATIENT WAS SEEN IN THE CLINIC 2 WEEKS AFTER THE EPISODE AND ¿WAS EDUCATED ON THE EVENT AND A LONG DISCUSSION OCCURRED FOR PATIENT UNDERSTANDING¿. THE EVENT WAS NOTED TO BE RELATED TO THE DEVICE OR THERAPY. THE SEVERITY OF THE EVENT WAS NOTED TO BE ¿SEVERE¿. THE OUTCOME WAS REPORTED AS ¿RESOLVED WITHOUT SEQUELA ON (B)(6) 2014¿. THE DEVICE SYSTEM WAS DELIVERING FENTANYL, BACLOFEN, AND PRIALT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION LATER RECEIVED REPORTED THE ETIOLOGY WAS MEDICATION TYPE, INTRATHECAL DRUG SPECIFICALLY COMPOUNDED FENTANYL 2500 MCG/ML, BACLOFEN 135 MCG/ML, AND PRIALT 3 MCG, THE RELATEDNESS TO DRUG WAS POSSIBLY RELATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION LATER REPORTED THAT A POCKET FILL OF ABOUT 1-2ML OF THE COMBINATION THERAPY FLUID HAD OCCURRED DURING THE REFILL WHICH CONTRIBUTED TO THE EVENT. THE PATIENT MADE A COMPLETE RECOVERY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER (HCP) VIA ISPR STUDY. THE PATIENT'S CARDIAC RESPONSE WAS SECONDARY TO OPIATE OVERDOSE. THE DRUG DOSE WAS DECREASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387018 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Hospitalization| L