BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2901300 · Received January 8, 2013

    Report

    Report Number
    3004209178-2013-00292
    Event Type
    Injury
    Date Received
    January 8, 2013
    Report Date
    December 10, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1151-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709SC, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: CATHETER; PRODUCT ID: 8709SC, SERIAL#: (B)(4), PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    AN MRI WAS BEING PERFORMED TO RULE OUT AN INTRATHECAL CATHETER GRANULOMA. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8573 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Other