BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4190079 · Received October 21, 2014

    Report

    Report Number
    3004209178-2014-20098
    Event Type
    Injury
    Date Received
    October 21, 2014
    Report Date
    November 30, 2016
    Manufacturer
    MEDTRONIC 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE CATHETER REVEALED NO SIGNIFICANT ANOMALY, CATHETER STRAIN RELIEF SHROUD NON SIGNIFICANT ANOMALY, MAY OR MAY NOT BE EXPLANT RELATED. LONGER APPLICABLE.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT¿S ENTIRE SYSTEM (CATHETER AND PUMP) WERE REPLACED ON (B)(6) 2014. THE REVISION WAS SCHEDULED BECAUSE OF THE PATIENT¿S COMPLAINTS OF INCREASED SPASTICITY. THE CATHETER WAS DISCONNECTED FROM THE PUMP AND THERE WAS SPONTANEOUS BACK FLOW OF CEREBROSPINAL FLUID (CSF). DESPITE NO EVIDENCE OF A PROBLEM, THE CATHETER AND PUMP WERE REPLACED. THE DOSE WAS DECREASED AFTER REPLACEMENT AND THE PATIENT WAS ADMITTED FOR OBSERVATION. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP WAS CONDUCTED TO OBTAIN THIS INFORMATION. A FOLLOW-UP REPORT WILL BE SUBMITTED IF MORE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PUMP WAS SENT IN FOR ANALYSIS BECAUSE THE HEALTHCARE PROFESSIONAL (HCP) WAS NOT ABLE TO DETERMINE AN ISSUE WITH THE PUMP OR CATHETER, AND THE CAUSE OF THE PATIENT¿S ISSUE WAS UNKNOWN. THE PATIENT WAS DOING FINE AT THIS TIME, BUT THE MANUFACTURER¿S REPRESENTATIVE HEARD THAT THE PATIENT¿S DOSE WAS ¿CREEPING BACK UP.¿

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER ON 2016-NOV-29. IT WAS REPORTED THAT THE PATIENT'S INTRATHECAL BACLOFEN DOSE WAS UP TO 3900 MCG/DAY AND THE PATIENT EXPERIENCED "BACLOFEN INSENSITIVITY" IN 2014 SO THE DAILY DOSE WAS DECREASED TO 2100 MCG/DAY ALTHOUGH THE PATIENT WAS STILL EXPERIENCING SEVERE SPASTICITY THAT BEGAN IN 2014.

    Description of Event or Problem · 1

    FOLLOWING IMPLANT, WITH THE DOSE AT 1000 MCG/DAY, THE PATIENT DID WELL FOR APPROXIMATELY 3 WEEKS. THE PATIENT THEN BEGAN HAVING INCREASED SPASTICITY. THE ¿DAILY DOSE WAS INCREASED UP TO 3000 MCG/DAY¿ AND THE PATIENT WAS STILL HAVING INCREASED SPASTICITY. A CATHETER DYE STUDY WAS DONE ON (B)(6) 2014 AND THE RADIOLOGIST WAS ABLE TO ASPIRATE 3 CC OF FLUID EASILY THROUGH THE CAP (CATHETER ACCESS PORT), BUT THOUGHT THERE WAS RESISTANCE WHEN INJECTING AND COULD NOT SEE DYE GOING THROUGH THE CATHETER. THERE HAD BEEN NO RESERVOIR VOLUME DISCREPANCIES. THE DEVICE SYSTEM WAS DELIVERING LIORESAL. THE INTERVENTIONS AND OUTCOME WERE NOT REPORTED. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668331 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR Hospitalization| R