BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 13453844 · Received February 4, 2022

    Report

    Report Number
    2182207-2022-00194
    Event Type
    Injury
    Date Received
    February 4, 2022
    Date of Event
    January 28, 2022
    Report Date
    February 4, 2022
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    UDI-DI
    00643169100831
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8731SC LOT#: N131393007, IMPLANTED: (B)(6), EXPLANTED: (B)(6) 2022, PRODUCT TYPE: CATHETER. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 8731SC, SERIAL/LOT #: (B)(4), UBD: 26-NOV-2009, 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) (190MCG/ML AT 9.12MCG (69.67MCG BEFORE)) AND MORPHINE DRUG, UNKNOWN (30MG/ML AT 1.44MG AFTER (11MG BEFORE)) VIA AN IMPLANTABLE PUMP FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT DURING NORMAL SCHEDULED PUMP REPLACEMENT DUE TO ELECTIVE REPLACEMENT INDICATOR (ERI), THE HEALTHCARE PROVIDER (HCP) WAS UNABLE TO ASPIRATE FROM THE CATHETER ACCESS PORT (CAP). BACK TABLE PRIME PERFORMED, NEW 8578 PUMP SEGMENT WAS ADDED TO THE BACK TABLE PRIME.  AFTER RECONNECTING THE NEW PUMP SEGMENT AND THE PUMP TO THE REMAINING CATHETER, THE HCP ATTEMPTED TO ASPIRATE FROM THE CAP AND AGAIN WAS UNSUCCESSFUL.HCP DECIDED TO REPLACE THE ENTIRE CATHETER. ALSO IN PREOPERATIVE, PATIENT STATED THEY NOT FEEL THEY WAS GETTING ADEQUATE PAIN RELIEF.  THE CAUSE OF EVENT WAS UNDETERMINED. DURING THE CATHETER EXPLORATION, NO CEREBRA SPINAL FLUID (CSF) FLOW OBSERVED FROM ASPIRATING THE CAP, OR FROM THE SPINAL SEGMENT AND THE CATHETER WAS REPLACED. THE ISSUE WAS RESOLVED AT THE TIME OF THIS REPORT. PATIENT ALSO HAD A PTM, 1MG DOSE X3 DOSES ALLOWED PER DAY THAT WAS DISABLED AFTER REPLACEMENT. PATIENT STATUS AT TIME OF THIS REPORT WAS ALIVE NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1562634 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-20 00643169100831

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Required Intervention