BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2032482 · Received March 23, 2011

    Report

    Report Number
    3004209178-2011-02233
    Event Type
    Injury
    Date Received
    March 23, 2011
    Date of Event
    January 1, 2011
    Report Date
    March 15, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PUMP HAS BEEN RETURNED TO THE MFR FOR ANALYSIS. A F/U REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    THE PT DEVELOPED AN INFECTION IN THE SPINE; DISCITIS UNRELATED TO THE PUMP. THE PT SYMPTOMS INCLUDED FEVER AND INCREASED PAIN. ALL TESTS/TREATMENTS WERE DONE AT THE HOSP; THIS REPORTER DID NOT HAVE THE DETAILS. THE PUMP AND CATHETER WERE EXPLANTED TO PREVENT CHRONIC COLONIZATION. THE EVENT WAS NOT ATTRIBUTED TO THE IMPLANTED DEVICES. THE OUTCOME WAS REPORTED AS "SERIOUS LIFE THREATENING INJURY/ILLNESS RECOVERED WITH SEQUELA". THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE SULFATE AND CLONIDINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| L| R EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709SC, LOT# N184826012