BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2082781 · Received May 3, 2011

    Report

    Report Number
    3004209178-2011-03198
    Event Type
    Injury
    Date Received
    May 3, 2011
    Date of Event
    November 1, 2010
    Report Date
    April 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
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS OF THE PUMP REVEALED NO ANOMALY FOUND; NORMAL DEVICE FUNCTION.

    Description of Event or Problem · 1

    THE PT HAD SKIN EROSION OVER THE PUMP WITH AN INFECTION. PT SYMPTOMS INCLUDED FEVER AND WOUND DRAINAGE. THE PT WAS HOSPITALIZED. THE PUMP AND CATHETER WERE EXPLANTED. THE PT OUTCOME WAS REPORTED WAS REPORTED AS "NO INJURY". THE DEVICE SYSTEM WAS USED TO DELIVER COMPOUNDED BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization| R IMPLANTED:| CATHETER: MODEL 8703W, LOT# L80790| EXPLANTED: