BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3123803 · Received May 22, 2013

    Report

    Report Number
    3004209178-2013-08022
    Event Type
    Injury
    Date Received
    May 22, 2013
    Report Date
    April 23, 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

    PRODUCT ID: 8709SC LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE CATHETER PRODUCT ID: 8709 LOT# SERIAL# (B)(4), IMPLANTED: 2004 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709SC SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER; PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, EXPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER.

    Description of Event or Problem · 1

    THE PATIENT'S DOCTOR LATER REPORTED THAT THE PUMP WAS NOT REMOVED DUE TO NORMAL BATTERY DEPLETION, AND IT WAS ¿JUST REMOVED AS A PRECAUTION¿. THEY RAN ALL THE DIAGNOSTICS ON THE DEVICE AND ¿EVERYTHING WAS NORMAL AND FUNCTIONING PROPERLY¿. THE HCP SPECULATED THAT THE PATIENT HAD AN INTERMITTENT OCCLUSION SOMEWHERE ALONG THE CATHETER. THEY DECIDED TO REPLACE THE WHOLE SYSTEM. THE PATIENT RECOVERED ¿FINE¿ WITH NO ISSUE, AND THEY WERE RECEIVING EFFECTIVE THERAPY.

    Description of Event or Problem · 1

    A HEALTHCARE PROFESSIONAL LATER REPORTED THAT THE CAUSE OF THE EVENT WAS UNKNOWN, BUT IT WAS ¿NOT PUMP¿. A CATHETER DYE STUDY AND PUMP ROTOR STUDY WAS PERFORMED AND THEY WERE WITHIN NORMAL LIMITS. AN X-RAY WAS PERFORMED, BUT THE RESULTS WERE NOT REPORTED. THE DRUG WAS ANALYZED AND ¿HAD COMPOUNDED DIFF PHARM¿. THE RESULTS WERE NOTED TO BE WITHIN NORMAL LIMITS. THE PUMP AND CATHETER WERE REPLACED. THE PATIENT WAS STILL IN A POSTOPERATIVE CONVALESCENT WOUND HEALING STAGE AFTER THE PUMP AND CATHETER REPLACEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT WAS HAVING INTERMITTENT OPIOID WITHDRAWAL THEN OVERDOSE. THE PHYSICIAN WAS SUSPECTING THAT THERE MAY BE A BLOCKAGE IN THE CATHETER. DURING A DYE STUDY, THERE WAS NO DYE THAT LEAKED OUT ALONG THE CATHETER LENGTH AND IT WAS VERIFIED ALL THE DYE GOING INTO THE SPINAL FLUID. THE PATIENT WAS CURRENTLY EXPERIENCING WITHDRAWAL AT HOME WHICH BEGAN 13 DAYS PRIOR TO THIS REPORT DATE AND HE WAS HOSPITALIZED FOR THREE DAYS. THE PUMP WAS DELIVERING MORPHINE SULFATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225899 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R