BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2968029 · Received February 19, 2013

    Report

    Report Number
    3004209178-2013-02835
    Event Type
    Injury
    Date Received
    February 19, 2013
    Report Date
    January 23, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER MODEL: 8711, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, EXPLANTED: UNKNOWN, ACCESSORY: MODEL: 8590-1, LOT# N071795, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS "COMPLAINING" OF UNSATISFACTORY/INADEQUATE ANALGESIA AND COULD NOT FEEL THE PATIENT THERAPY MANAGER. A CONTRAST STUDY WAS DONE AND SHOWED "NORMAL CATH TIP LOCATION AT T12 AND NO SIGNS OF GRANULOMA". THE PUMP WAS INDICATING AN ELECTIVE REPLACEMENT WITHIN 3 MONTHS. THE PUMP WAS REPLACED AND THE PATIENT RECOVERED WITHOUT SEQUELAE. THE PATIENT WAS BEING INFUSED WITH DILAUDID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71638 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Required Intervention