BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4110442 · Received September 23, 2014

    Report

    Report Number
    3007566237-2014-02665
    Event Type
    Injury
    Date Received
    September 23, 2014
    Report Date
    September 5, 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 Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8780, SERIAL # UNKNOWN, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8780, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT AT THE REVISION THE PATIENT RECEIVED A NEW PUMP AND WAS NOW RECEIVING EFFECTIVE THERAPY AND DOING VERY WELL. FLEX DOSING WAS USED AND FOUND VERY USEFUL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ¿OTHER OR UNKNOWN¿ CATHETER ISSUE, WHICH WAS SPECIFIED AS, THE ¿PATIENT WAS NOT RECEIVING THERAPY, LOSS OF EFFICACY FROM BACLOFEN.¿ ADDITIONALLY, AN ¿OTHER OR UNKNOWN¿ PUMP ISSUE WAS REPORTED, WHICH WAS SPECIFIED AS, THE ¿PATIENT WAS NOT RECEIVING ADEQUATE ITB (INTRATHECAL BACLOFEN) THERAPY.¿ PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT WERE REPORTED AS ¿LESS THAN 50% THERAPY RELIEF.¿ NO DIAGNOSTIC TESTING OR TROUBLESHOOTING WAS PERFORMED, AND THE ISSUE WAS NOT RESOLVED; IT WAS UNKNOWN IF ANY ACTIONS WERE REQUIRED AS A RESULT OF THE EVENT. THE CATHETER AND PUMP REMAINED IMPLANTED AND IN SERVICE. THE PATIENT¿S STATUS WAS REPORTED AS ALIVE, NO INJURY. THE PUMP WAS BEING USED TO DELIVER LIORESAL. NO INTERVENTIONS OR OUTCOME WERE 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

    IT WAS FURTHER REPORTED THAT THE INITIAL IMPLANT DATE WAS (B)(6) 2013. NO ISSUES WERE NOTED UP UNTIL (B)(6) 2013, WITH THE ONSET OF INCREASED SPASMS. SUBSEQUENTLY, INVESTIGATIONS WERE CARRIED OUT WHICH INCLUDED A DYE TEST, ROLLER STUDY, AND ASPIRATION FORM THE CAP (CATHETER ACCESS PORT). THE INVESTIGATIONS LED TO THE DECISION THAT THE CATHETER WAS BLOCKED. ON (B)(6) THE LIORESAL CONCENTRATION WAS INCREASED TO 710 MICROGRAMS/DAY. IT WAS SUBSEQUENTLY REPORTED THAT EFFECTIVE THERAPY HAD BEEN RESUMED, BUT AS A PRECAUTION, THE NEUROSURGEON WAS STILL LOOKING TO REVISE THE CATHETER "JUST IN CASE THIS HAPPENS AGAIN." A COLLEAGUE OF THE COMPANY REPRESENTATIVE WAS NOTED TO BE ATTENDING THE CATHETER REVISION PROCEDURE, AND WOULD OBTAIN THE CATHETER FOR INVESTIGATION IF THE NEUROSURGEON WANTED IT INVESTIGATED. THE OUTCOME REGARDING THE EVENT WAS NOT REPORTED. FURTHER FOLLOW-UP IS BEING CONDUCTED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592375 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention