BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 13315322 · Received January 21, 2022

    Report

    Report Number
    3004209178-2022-00944
    Event Type
    Injury
    Date Received
    January 21, 2022
    Report Date
    January 21, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00643169530126
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8780, SERIAL#: (B)(4), EXPLANTED: (B)(6) 2022, PRODUCT TYPE: CATHETER. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 8780, SERIAL/LOT #: (B)(4), UBD: 15-APR-2021, 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 LIORESAL (BACLOFEN) (200 CG AT 1865 MCG) VIA AN IMPLANTABLE PUMP FOR INTRACTABLE SPASTICITY. IT WAS REPORTED THAT THE HEALTHCARE PROVIDER (HCP) WAS NOTIFIED LAST NIGHT THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH BACLOFEN WITHDRAWAL SYMPTOMS. THE HCP DECIDED TO DO A DYE STUDY THIS MORNING TO SEE IF CATHETER WAS PATENT. THE HCP COULD NOT GET CEREBRA SPINAL FLUID (CSF) FLOW SO THE PHYSICIAN DECIDED TO REPLACE THE OLD CATHETER. THE ISSUE WAS RESOLVED AT TIME OF THE REPORT, THE PATIENT STATUS WAS ALIVE NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858850 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40 00643169530126

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| H