BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4220975 · Received November 3, 2014

    Report

    Report Number
    3004209178-2014-20853
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    October 14, 2014
    Report Date
    October 14, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709SC, LOT# N130027020, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED AN OPIOID OVERDOSE AND WAS ADMITTED TO THE EMERGENCY ROOM. THE DEVICE SYSTEM WAS USED TO DELIVER HYDROMORPHONE. THE SPECIFIC SYMPTOMS, INTERVENTION, 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
    703311 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Other