BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 7629666 · Received June 22, 2018

    Report

    Report Number
    3004209178-2018-14114
    Event Type
    Malfunction
    Date Received
    June 22, 2018
    Date of Event
    January 1, 2016
    Report Date
    June 22, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00643169100824
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A PATIENT REGARDING THEIR IMPLANTABLE DRUG INFUSION DEVICE. THE DRUG BEING DELIVERED WAS MORPHINE (UNKNOWN) AT AN UNKNOWN DOSE AND CONCENTRATION. THE REASON FOR USE WAS NON-MALIGNANT PAIN. IT WAS REPORTED THAT IN 2016 THE PUMP RAN DRY. THE PATIENT STATED "I HAD THIS THING RUN... OH I DON'T WANT TO GO THROUGH THAT AGAIN, I'M WORKING ON GETTING IT OUT." TO CLARIFY, THE PATIENT MENTIONED THE PUMP "WENT DRY" ONCE IN 2016 STATING "I DON'T EVEN WANT TO GO THERE, IT WAS HORRIBLE." THEY STATED THAT DUE TO A MOVE, SHE COULD NOT FIND A HEALTHCARE PROFESSIONAL (HCP) DUE TO INSURANCE REASONS AND IN THE MEANTIME HER PUMP WENT DRY. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472624 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40 00643169100824

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR