BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 14837543 · Received June 27, 2022

    Report

    Report Number
    3004209178-2022-08173
    Event Type
    Injury
    Date Received
    June 27, 2022
    Report Date
    June 27, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00643169630505
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS:PRODUCT ID 8780 LOT# SERIAL# (B)(4) IMPLANTED: (B)(6) 2021 EXPLANTED: (B)(6) 2022 PRODUCT TYPE CATHETER. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 8780, SERIAL/LOT #: (B)(4), UBD: 31-DEC-2022, 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 RECEIV ING UNKNOWN MORPHINE DRUG (20 AT 8.114) VIA AN IMPLANTABLE PUMP FOR NON-MALIGNANT PAIN. IT WAS REPORTED THAT  THE PHYSICIAN STATED THE PATIENT HAD BEEN ROTATING THE PUMP IN THE POCKET. DURING SURGERY, PUMP WAS DISCONNECTED FROM CATHETER AND NO CEREBRA SPINAL FLUID (CSF) FLOW WAS NOTED FROM EXISTING CATHETER. PHYSICIAN REPLACED WITH NEW 8780 AND DESIRED TO REPLACE WITH THE LARGER 40 ML PUMP. CSF FLOW WAS VISUALIZED WITH NEW CATHETER AND PUMP. NO SYMPTOMS WERE REPORTED. NO KNOWN EXTERNAL FACTORS WERE REPORTED. THE ISSUE WAS RESOLVED, PATIENT WAS ALIVE, NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2043049 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20 00643169630505

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention