BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3201641 · Received July 2, 2013

    Report

    Report Number
    3007566237-2013-01009
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    February 10, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8709, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE CATHETER; PRODUCT ID 8709, SERIAL #(B)(4), IMPLANTED: (B)(6) 2005, EXPLANTED: (B)(6) 2006, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    A PROBLEM WAS REPORTED. COMPANY REPRESENTATIVE REPORTED THAT PUMP WAS REPLACED DUE TO AN ISSUE. THE ¿ISSUE¿ WAS NOT SPECIFIED. NO PATIENT SYMPTOMS WERE REPORTED. NO PATIENT OUTCOME REPORTED. SYSTEM USED TO DELIVER LIORESAL. A REPORT WILL BE PROVIDED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303274 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention