BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 14563417 · Received June 1, 2022

    Report

    Report Number
    2182207-2022-00938
    Event Type
    Injury
    Date Received
    June 1, 2022
    Date of Event
    January 1, 2022
    Report Date
    June 1, 2022
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8780, SERIAL#: (B)(4), PRODUCT TYPE: CATHETER. THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 8780, SERIAL/LOT #: (B)(4), UBD: 03-JUN-2017, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS RECEIVING GABLOFEN (1000 MCG/ML AT 121 MCG/DAY) VIA AN IMPLANTABLE PUMP FOR INTRACTABLE SPASTICITY. IT WAS REPORTED THAT THE PATIENT WAS NOT EXPERIENCING ANY SIGNS OR SYMPTOMS. NO KNOWN ENVIRONMENTAL EXTERNAL OR PATIENT FACTORS WAS NOTED. THE HEALTHCARE PROVIDER (HCP) WAS REPLACING THE PUMP FOR NORMAL END OF LIFE  AND COULD NOT DRAW ANY FLUID OUT OF THE CATHETER WHEN CHECKING FOR PATENCY AND DECIDED TO REPLACE THE ENTIRE CATHETER. WHILE REMOVING THE OLD CATHETER ONLY A SMALL AMOUNT CAME OUT OF THE SPINE. IT WAS APPARENT THAT THE CATHETER HAD BROKEN OFF IN THE PATIENT BACK NEAR THE SPINE. X-RAY SHOWED THE OTHER PORTION OF THE INTRATHECAL CATHETER IN THE SPINE SEGMENT. THE PORTION THAT WAS REMOVED WAS SENT TO BE CLEANED BY THE HOSPITAL AND IT HAS BEEN REQUESTED TO BE RETURNED TO  MEDTRONIC. A NEW CATHETER WAS PLACED AND CEREBRA SPINAL FLUID WAS CONFIRMED. THE ISSUE WAS RESOLVED, PATIENT WAS ALIVE NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305020 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Required Intervention