BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 8685280 · Received June 10, 2019

    Report

    Report Number
    3004209178-2019-11277
    Event Type
    Malfunction
    Date Received
    June 10, 2019
    Date of Event
    May 16, 2019
    Report Date
    June 10, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00643169630505
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: A810, LOT/SERIAL# N/A, IMPLANTED: N/A, EXPLANTED: N/A, PRODUCT TYPE: SOFTWARE; UBD: N/A, UDI#: N/A. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT RECEIVING 10 MG/ML OF MORPHINE AT 6.1 MG/DAY VIA AN IMPLANTABLE PUMP FOR NON-MALIGNANT PAIN AND FAILED BACK SURGERY SYNDROME. IT WAS REPORTED A PROGRAMMING ERROR OCCURRED. THE WRONG DRUG CONCENTRATION WAS ENTERED WITH THE CLINICIAN PROGRAMMER TABLET AND THERAPY APPLICATION, SOFTWARE VERSION 1.0.7493. THE HCP STATED THIS OCCURRED THE LAST TIME THE PATIENT WAS REFILLED ON (B)(6) 2019. THE PATIENT'S CONCENTRATION WAS CHANGED FROM 10 MG/ML OF MORPHINE TO 20 MG/ML OF MORPHINE, HOWEVER INSTEAD OF READING 20 MG/ML OF MORPHINE THE PUMP STILL READ 10 MG/ML OF MORPHINE. DOSING CONSIDERATION WERE REVIEWED BASED ON THE PROGRAMMING ERROR. IT WAS REVIEWED THE ENTIRE SYSTEM NOW HAD 20 MG/ML OF MORPHINE, THEREFORE A BRIDGE BOLUS WAS NO LONGER NEEDED. NO SYMPTOMS WERE REPORTED. THE HCP REPORTED THE PATIENT WAS DOING FINE WITH THE HIGHER DOSE. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477878 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20 00643169630505

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR