BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2968257 · Received February 19, 2013

    Report

    Report Number
    3004209178-2013-02839
    Event Type
    Injury
    Date Received
    February 19, 2013
    Report Date
    January 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009. PRODUCT TYPE: CATHETER: PRODUCT ID 8590-1, LOT# N233815, IMPLANTED: (B)(6) 2009. PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD GONE TO THE EMERGENCY ROOM WITH A RETURN OF PAIN SYMPTOMS. LATER THAT DAY, A ROTOR STUDY WAS TO BE PERFORMED. TWELVE DAYS LATER, IT WAS REPORTED THAT THE PATIENT HAD BEEN ADMITTED TO THE HOSPITAL WITH INCREASED PAIN IN HIS LEGS. TWO DAYS EARLIER, A DYE STUDY HAD BEEN PERFORMED THAT SHOWED THE CATHETER WAS INTACT AND THE DYE WAS ENTERING THE INTRATHECAL SPACE. A CT SCAN WAS ALSO PERFORMED AND IT WAS FOUND THAT THE CATHETER WAS STILL IN THE INTRATHECAL SAC. ADDITIONALLY, THE PUMP LOGS WERE READ AND SHOWED NORMAL FUNCTION OF THE PUMP WITH NO MOTOR STALLS. AT THE TIME OF REPORT, THERE WAS NO FURTHER PLANNED INTERVENTION AND THE PATIENT'S STATUS WAS UNKNOWN. THE DRUGS USED IN THIS SYSTEM WERE MORPHINE AND BUPIVACAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71158 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization