BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1800892 · Received August 10, 2010

    Report

    Report Number
    3004209178-2010-06009
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 13, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    ON (B)(6)-2010, IT WAS REPORTED THAT A PATIENT EXPERIENCED INCREASED BASELINE SPASTICITY AND A RETURN OF THE FOLLOWING SYMPTOMS: IRRITABILITY, RASH, AND ITCHING. THE PATIENT RESPONDED TO A 30 MCG BOLUS, BUT THE SYMPTOMS REAPPEARED. A SECOND 30 MCG BOLUS WAS GIVEN AND THE PATIENT RESPONDED AGAIN. A DYE STUDY WAS PERFORMED BUT THE CATHETER COULD NOT BE ASPIRATED. A SECOND DYE STUDY WAS PERFORMED THE NEXT DAY, WHICH ALSO RESULTED IN AN INABILITY TO ASPIRATE FROM THE CATHETER. THIS TIME THE PHYSICIAN PUSHED THROUGH ANYWAY, AND THE DYE HAD FLOWED THROUGH NICELY AND APPEARED IN THE INTRATHECAL SPACE. A CT SCAN ALSO SHOWED GOOD FLOW OF THE DYE INTRATHECALLY. ON (B)(6)-2010, THE PATIENT RETURNED TO THE HOSPITAL WITH INCREASED SPASTICITY, CLONUS, AND SPASMS. WITHDRAWAL WAS ALSO REPORTED. THE CATHETER WAS NOTED AS FRACTURED, AND A REPLACEMENT/REVISION SURGERY WAS SCHEDULED. ON (B)(6)-2010, A PUMP ISSUE OCCURRED, AND MOTOR STALL WAS DISCUSSED. A ROLLER STUDY WAS PERFORMED AND REPEATED, WHICH SUGGESTED THAT THERE WAS NO MOVEMENT OF THE PUMP ROLLERS. A SINGLE BOLUS OF 30 MCG OVER 10 MINUTES WAS PERFORMED, AND ROLLER MOVEMENT WAS DETECTED. THE PHYSICIAN HAD DECIDED TO REPLACE THE PUMP ALONG WITH THE CATHETER. THE PATIENT WAS NOTED AS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention IMPLANTED:| CATHETER: MODEL 8709SC, LOT# N192954005| EXPLANTED: