BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4792218 · Received May 22, 2015

    Report

    Report Number
    3004209178-2015-09600
    Event Type
    Malfunction
    Date Received
    May 22, 2015
    Report Date
    April 29, 2015
    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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: CATHETER. PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A CHANGE IN THERAPEUTIC EFFECT. THE PATIENT WAS IN WITHDRAWAL AT THE TIME OF THE REPORT. THE PATIENT WAS WORKING WITH HER HEALTH CARE PROVIDER (HCP). THE HCP HAD CHECKED THE PUMP AND THE CATHETER. DIAGNOSTICS WERE DONE AND IT WAS FOUND THAT THE MEDICATION WAS FLOWING FREELY BUT IF THE PATIENT WENT OFF THE ORAL MEDICATION SHE WOULD GET INCREASED SPASTICITY, ITCHING, AND A RASH. THEY DID FIND THAT THE PATIENT¿S CATHETER MOVED BUT IT WAS DETERMINED THAT SHOULDN¿T HAVE ANYTHING TO DO WITH WHAT SHE WAS EXPERIENCING. ON (B)(6) 2015, THE HCP TOOK THE BACLOFEN OUT OF THE PUMP TO ASSESS VOLUME AND THE PUMP WAS REFILLED. A DYE STUDY WAS ALSO DONE ON THAT DATE. THE PUMP WAS INFUSING BACLOFEN (UNKNOWN). ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT INITIALLY EXPERIENCED AN INCREASE IN SPASTICITY/STIFFNESS ON (B)(6) 2015, AND THEN THEY HAD A FURTHER INCREASE IN STIFFNESS, ITCHING, AND HAD A RASH ON (B)(6) 2015. ON (B)(6) 2015, THE PATIENT HAD SEVERE CLONUS. THE CAUSE OF THE ISSUE WAS NOT KNOWN YET. THE PUMP RESIDUAL VOLUME WAS AS EXPECTED. THE CATHETER DYE STUDY FLOWED TO THE EPIDURAL SPACE BUT WAS NOW 2 LEVELS LOWER. A COMPUTED TOMOGRAPHY (CT) SCAN WAS DONE BUT THE RESULTS WERE UNAVAILABLE. THE PATIENT WAS ON 30MG OF ORAL BACLOFEN TWICE DAILY, WHICH WAS MUCH HIGHER THAN USUAL, TO CONTROL THE SYMPTOMS. THE PATIENT HAD NOT RECOVERED AND THE SYMPTOMS/ISSUES WERE STILL ONGOING. THE PATIENT WAS WORKING WITH THEIR DOCTOR OR A MANUFACTURING REPRESENTATIVE. NO INTERVENTIONS OR OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. A FOLLOW-UP REPORT WILL BE SUBMITTED IF MORE INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335881 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1