BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 6857706 · Received September 12, 2017

    Report

    Report Number
    3004209178-2017-19161
    Event Type
    Malfunction
    Date Received
    September 12, 2017
    Date of Event
    September 1, 2016
    Report Date
    September 12, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00643169100824
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID NEU_UNKNOWN_CATH, PRODUCT TYPE CATHETER.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT RECEIVING INTRATHECAL MORPHINE AT 48.62 MG/DAY AT A CONCENTRATION OF ¿21%¿. IT WAS REPORTED THAT THE PATIENT WANTED TO KNOW THE DATE IN WHICH SHE HAD HER LAST CATHETER IMPLANTED. THE PATIENT WAS CONCERNED BECAUSE SHE HAD BEEN TOLD BY HER HEALTHCARE PROVIDER (HCP) THAT HCPS DO NOT REMOVE THE CATHETERS AND JUST LEAVE THEM IN AND IMPLANT ANOTHER ONE. THE PATIENT WAS ALSO CONCERNED ABOUT THE DOCTOR MENTIONING THEY WANTED TO SPLICE THE CATHETER. THE PATIENT¿S CATHETER SHE HAD RIGHT NOW WAS NOT DELIVERING HER MEDICATION TO HER. THE HCP PERFORMED A DYE STUDY IN (B)(6) 2017 AND COULD NOT GET INTO THE PUMP. THEY THOUGHT THE PROBLEM WAS THE CATHETER MAY HAVE BEEN KINKED OR MOVING. THE PUMP WAS NOT RELIEVING THE PATIENT¿S PAIN. IT WAS UNKNOWN IF THIS WAS A SUDDEN OR GRADUAL CHANGE IN THERAPY/SYMPTOMS. THE PATIENT HAD NO PAIN RELIEF SINCE ¿LAST (B)(6) (2016)¿. IT WAS NOTED THAT THE PATIENT LOVED THE PUMP WHEN IT WORKED. THERE WAS NO OUT OF BOX FAILURE REPORTED ANDNO MEDICAL OR THERAPY PROBLEM ASSOCIATED WITH SMALL PARTS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639193 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40 00643169100824

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR