BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4232988 · Received November 6, 2014

    Report

    Report Number
    3004209178-2014-21098
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 29, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8782, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PROCEDURE THE CATHETER WAS PLACED INTRATHECALLY BUT THEN WHEN THE HEALTH CARE PROVIDER (HCP) ATTEMPTED TO REMOVE THE GUIDEWIRE, IT BECAME STUCK IN THE CATHETER. THE WIRE WOULD NOT COME OUT OF THE CATHETER AND THE HANDLE BROKE OFF OF THE WIRE AFTER PULLING. THE CATHETER WAS THEN REMOVED AND A NEW 8780 WAS USED WITHOUT INCIDENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THE PATIENT¿S STATUS AT THE TIME OF THIS REPORT WAS LISTED AS ¿ALIVE ¿ NO INJURY¿. THE TYPE OF MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714732 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00043 YR