BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3232549 · Received July 18, 2013

    Report

    Report Number
    3004209178-2013-11921
    Event Type
    Injury
    Date Received
    July 18, 2013
    Report Date
    June 26, 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
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8598A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: CATHETER: PRODUCT ID 8 709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE DISTAL SEGMENT OF THE CATHETER MIGRATED FROM THE INTRATHECAL SPACE. A CATHETER REVISION WAS PLANNED FOR (B)(6). THERE WERE NO PATIENT SYMPTOMS/INJURIES RELATED TO THIS EVENT THE PATIENT STATUS WAS INDICATED AS ALIVE ,NO INJURY,NO ADVERSE EVENT. THE PUMP WAS DELIVERING LIORESAL. IT WAS LATER REPORTED THE PATIENT UNDERWENT A CATHETER REVISION. THE SPINAL SEGMENT WAS REPLACED IN THE INTRATHECAL SPACE AND CONNECTED TO THE EXISTING PROXIMAL CATHETER. THE PATIENT PUMP WAS RESTARTED AT 100 MCG/DAY, 2000 MCG/M, LIORESAL. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2013 WITH IMPROVED THERAPEUTIC EFFICACY. HE WILL FOLLOW UP WITH HIS MANAGING PHYSICIAN FOR FURTHER NEEDED PUMP TITRATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333493 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention