BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2933746 · Received January 29, 2013

    Report

    Report Number
    3007566237-2013-00311
    Event Type
    Injury
    Date Received
    January 29, 2013
    Date of Event
    September 14, 2004
    Report Date
    January 4, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004-, EXPLANTED: (B)(6) 2005, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    A LUMBAR INCISION INFECTION WAS REPORTED. EXAMINATION AND PALPATION INDICATED SIGNS OF INFECTION ON (B)(6) 2004. THE ETIOLOGY WAS NOTED AS "INCISIONAL SITE/DEVICE TRACT," AND WAS NOTED TO NOT HAVE BEEN RELATED TO THE IMPLANT PROCEDURE, DEVICE, OR THERAPY. THE BACK WOUND WAS NOTED TO HAVE BEEN "MILDLY ERYTHEMATOUS." IT WAS NOTED THAT THE ENTIRE SYSTEM WAS EXPLANTED IN (B)(6) 2005, AND THE OUTCOME WAS NOTED TO HAVE BEEN RESOLVED WITHOUT SEQUELAE ON (B)(6) 2005. THE MEDICATIONS USED WITHIN THE SYSTEM WERE NOTED TO BE "COMPOUNDED BACLOFEN OR MORPHINE SULFATE" NO ADDITIONAL INFORMATION WAS AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39470 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00041 YR Required Intervention