BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2862558 · Received December 10, 2012

    Report

    Report Number
    3004209178-2012-11305
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    November 8, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 8709SC SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE CATHETER: PRODUCT ID 8590-1 LOT# N317031, IMPLANTED: 2012 (B)(6), PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT'S INCISION "ABOVE THE CATHETER" STARTED LEAKING CLEAR FLUID ON (B)(6) 2012. THE PATIENT WAS HAVING NO OTHER SYMPTOMS. THE PATIENT HAD "OTHER ISSUES" THAT NEEDED TO BE TAKEN CARE OF. THE PATIENT'S OTHER ISSUES WERE FURTHER NOTED AS NOT BEING RELATED TO THE PUMP. A PHYSICIAN REPORTED THAT LEAKING FROM THE LUMBAR SITE OCCURRED. THE CAUSE OF THE EVENT WAS DUE TO A COMPLICATION OF A SPINAL FUSION. THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2012 TO (B)(6) 2012 AT A CHILDREN'S HOSPITAL. THE PATIENT AGAIN REQUIRED HOSPITALIZATION; THE PUMP AND CATHETER WERE EXPLANTED. THE PATIENT'S "SERIOUS INJURY/ILLNESS" WAS ONGOING. THE PUMP WAS DELIVERING LIORESAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R