BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4232038 · Received November 6, 2014

    Report

    Report Number
    3004209178-2014-21065
    Event Type
    Injury
    Date Received
    November 6, 2014
    Report Date
    October 17, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    THE CATHETER HAD DETACHED FROM THE SPINE THREE TIMES, THE SECOND TIME WAS IN (B)(6) 2011 (SEE MANUFACTURER REPORT #3004209178-2014-21062 FOR THE FIRST TIME) THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE. THE SPECIFIC SYMPTOMS, INTERVENTIONS AND OUTCOME WERE NOT REPORTED. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715235 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Required Intervention