BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3192305 · Received June 27, 2013

    Report

    Report Number
    3004209178-2013-10952
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 1, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8786, SERIAL # UNKNOWN, PRODUCT TYPE ACCESSORY; PRODUCT ID 8787, SERIAL # UNKNOWN, PRODUCT TYPE ACCESSORY; PRODUCT ID 8780, SERIAL # (B)(4), PRODUCT TYPE CATHETER; PRODUCT ID 8780, SERIAL # (B)(4), PRODUCT TYPE CATHETER; PRODUCT ID 8786, SERIAL # UNKNOWN, PRODUCT TYPE ACCESSORY; PRODUCT ID 8787, SERIAL # UNKNOWN, PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ISSUE OCCURRED REGARDING A CATHETER INSERTION OR ADVANCEMENT. WHILE DOING A CATHETER IMPLANT/REVISION PROCEDURE, THE HEALTH CARE PROVIDER (HCP) FELT THE NEEDLE WAS NOT WORKING BECAUSE HE COULDN¿T FEED THE CATHETER THROUGH IT VERY WELL. IT WAS LATER REPORTED THE DEVICE SYSTEM HAD BEEN USED TO DELIVER BACLOFEN. THE EVENT OCCURRED DURING A NEW IMPLANT AND WHILE TRYING TO GET INTO THE INTRATHECAL SPACE, THE HCP HAD SAID THE NEEDLE WASN¿T WORKING PROPERLY. THE HCP REPORTEDLY OBTAINED A NEW NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294396 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00038 YR