BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 7452547 · Received April 23, 2018

    Report

    Report Number
    3004209178-2018-08628
    Event Type
    Injury
    Date Received
    April 23, 2018
    Date of Event
    February 1, 2018
    Report Date
    June 6, 2018
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    UDI-DI
    00643169100831
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER WAS RETURNED, AND ANALYSIS FOUND A KINK IN THE CATHETER BODY. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8780, SERIAL (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 8780, SERIAL/LOT (B)(4), UBD: 23-MAY-2015, (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 8780, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2018, PRODUCT TYPE: CATHETER. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS RECEIVING 2000 MCG/ML FENTANYL AT 99.7 MCG/DAY, 15.6 MG/ML BUPIVACAINE AT 0.778 MG/DAY, AND 1 MG/ML MORPHINE AT 0.0498 MG/DAY VIA AN IMPLANTABLE PUMP FOR NON-MALIGNANT PAIN AND LUMBAR RADICULOPATHY. IT WAS REPORTED THAT TWO MONTHS AGO, THE PATIENT HAD DEVELOPED A RETURN OF HER PAIN. ON (B)(6) 2018, THE DOCTOR ATTEMPTED A CATHETER ACCESS PORT (CAP) DYE STUDY AND WAS UNABLE TO ASPIRATE FROM THE CAP. TODAY [(B)(6) 2018], THE PATIENT WAS HAVING A CATHETER REVISION AND THEY FOUND A KINK AT THE PROXIMAL END OF THE ANCHOR. NO FURTHER ISSUES WERE REPORTED OR ANTICIPATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) AND A DEVICE MANUFACTURER REPRESENTATIVE. IT WAS REPORTED THAT THE PATIENT HAD A CATHETER REVISION ON (B)(6) 2018, AND A NEW PUMP WAS PLACED THAT DAY AS WELL. THE ELECTIVE REPLACEMENT INDICATOR WAS NOTED TO BE 23 MONTHS. IT WAS FURTHER REPORTED THAT THE CATHETER WAS DISLODGED AND COILED IN THE TISSUE. A CATHETER KINK WAS ALSO NOTED. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294181 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20 00643169100831

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention