BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3103266 · Received May 9, 2013

    Report

    Report Number
    3004209178-2013-07476
    Event Type
    Injury
    Date Received
    May 9, 2013
    Report Date
    April 15, 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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT A CATHETER STUDY WAS PERFORMED. THE CATHETER WAS FOUND TO BE OCCLUDED AND A REVISION WAS SCHEDULED LATER IN MAY. IT WAS LATER REPORTED THAT THE ORIGIN OF THE OCCLUSION WAS AN 8709 OBSTRUCTION.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT DYE WAS NOT ABLE TO BE PUSHED DOWN THE CATHETER DURING DIAGNOSTICS. THE CATHETER CONNECTION TO THE PUMP WAS RESEATED AND, AT THE TIME OF THE REPORT, WAS RUNNING WITHOUT ISSUE. IT WAS BELIEVED THAT THE CAUSE WAS MISALIGNMENT OF THE CATHETER CONNECTOR WHEN THE PUMP WAS REVISED. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP CONTAINED 37 ML IN THE RESERVOIR AT REFILL, AND IT SHOULD HAVE CONTAINED ROUGHLY 3 ML. IT WAS UNKNOWN WHETHER THERE WAS A PUMP OR CATHETER FAILURE AT THE TIME OF THE REPORT. THE PATIENT'S OUTCOME WAS NOTED AS "NO HARM." THE MEDICATION USED WITHIN THE SYSTEM WAS COMPOUNDED BACLOFEN. THE PATIENT'S PHYSICIAN WAS NOTED TO HAVE CHECKED FOR CATHETER PATENCY BEFORE CONNECTING TO THE PATIENT'S NEW PUMP. IT WAS LATER REPORTED THAT THERE WAS STILL 30-37 ML IN THE PUMP AND NO MESSAGES TO INDICATE POR/MOTOR STALLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202877 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention