BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3030407 · Received April 2, 2013

    Report

    Report Number
    3004209178-2013-04464
    Event Type
    Injury
    Date Received
    April 2, 2013
    Report Date
    March 4, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: CATHETER MODEL 8703, LOT# J92103110, IMPLANTED: (B)(6) 1993; CATHETER MODEL 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT HAD 'ISSUES,' INCREASED SPASMS, WAS SUFFERING 'QUITE A BIT,' WAS PRONE TO URINARY TRACT INFECTIONS (UTI). PATIENT WENT TO THE HOSPITAL, UTI WAS RULED OUT WITH CULTURE. CATHETER DYE STUDY WAS ATTEMPTED, UNABLE TO ASPIRATE SIDE PORT AND THE CATHETER WAS REPLACED THE SAME DAY, OLD CATHETER LEFT IN PLACE. THE EXACT SITE OF CATHETER ISSUE WAS UNKNOWN AS IT WAS 'NOT COMPLETELY EXPLORED.' A SUCCESSFUL ROTOR STUDY WAS DONE IN THE OPERATING ROOM. ORAL BACLOFEN HAD BEEN STARTED THE DAY OF SURGERY BUT IT DIDN'T HELP 'MUCH.' AFTER CATHETER REPLACEMENT WAS RESTARTED ON INTRATHECAL BACLOFEN WITH 'BETTER RELIEF.' THE DEVICE SYSTEM WAS USED TO INFUSE COMPOUNDED BACLOFEN AND BUPIVACAINE.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE CATHETER WAS "BROKEN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133945 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00039 YR Required Intervention