BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 13102412 · Received December 28, 2021

    Report

    Report Number
    3004209178-2021-19068
    Event Type
    Injury
    Date Received
    December 28, 2021
    Date of Event
    December 17, 2021
    Report Date
    December 28, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00763000422608
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709SC, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: CATHETER. THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 8709SC, SERIAL/LOT #: (B)(4), UBD: , UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ON (B)(6) 2021 (B)(4) (CON, REP): CONSUMER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS RECEIVING MORPHINE DRUG, UNKNOWN (10MG/ML AT 0.989) VIA AN IMPLANTABLE PUMP FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE PATIENT WAS NOT GETTING PAIN RELIEF FOR APPROXIMATELY 3 MONTHS. THERE WAS NO ENVIRONMENTAL OR EXTERNAL FACTORS THAT HAVE LED TO THE ISSUE. IT WAS MENTIONED THAT THE INTRATHECAL SEGMENT WAS NOT DRIPPING / NOT FLOWING BACK CEREBRA SPINAL FLUID (CSF). A NEW INTRATHECAL SEGMENT WAS PLACED AND THE ISSUE WAS RESOLVED AT TIME OF THIS REPORT. THE PATIENT STATUS AT TIME OF THIS REPORT WAS ALIVE NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1997549 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20 00763000422608

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention