BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2980760 · Received February 27, 2013

    Report

    Report Number
    3004209178-2013-03113
    Event Type
    Injury
    Date Received
    February 27, 2013
    Report Date
    January 31, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 8709SC LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SCHEDULED FOR A CATHETER REVISION ON (B)(6) 2013. THE REASON FOR THE REVISION WAS UNKNOWN. NO PATIENT SYMPTOMS WERE REPORTED, AND THE PATIENT'S OUTCOME WAS UNKNOWN AS OF THE DATE OF THIS REPORT. THE MEDICATION USED WITHIN THE SYSTEM WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS SUBMISSION. A FOLLOW-UP REPORT WILL BE SUBMITTED IF FURTHER INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT EXPERIENCED SPASTICITY. THE CATHETER ISSUE WAS UNKNOWN; HOWEVER, THE ENTIRE CATHETER WAS REPLACED AS A PRECAUTION. THE PATIENT OUTCOME WAS REPORTED AS ¿FINE¿ AND THE REPORTED BELIEVED THE PATIENT WAS RECEIVING EFFECTIVE THERAPY. THE DEVICE SYSTEM WAS USED TO DELIVER COMPOUNDED BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85412 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention