BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3963039 · Received July 29, 2014

    Report

    Report Number
    3004209178-2014-13622
    Event Type
    Injury
    Date Received
    July 29, 2014
    Report Date
    July 9, 2014
    Manufacturer
    MEDTRONIC 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709, LOT # J11198R49, IMPLANTED: (B)(6) 2002, PRODUCT TYPE CATHETER; PRODUCT ID 8596SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT COMPLAINED OF PAIN THAT WAS NOT CONTROLLED BY THE PUMP. A DYE STUDY WAS PERFORMED BY THE MANAGING PHYSICIAN ON THE DAY OF REPORT. THE CATHETER WAS EASILY ASPIRATED AND NO OBVIOUS CATHETER MALFUNCTIONS WERE NOTED. THE DOCTOR REPORTED THAT THE PATIENT WAS HAVING LEG HEAVINESS AND WEAKNESS RECENTLY. THE DOCTOR WAS CONCERNED ABOUT A GRANULOMA AS THE DRUG CONCENTRATION WAS NOTED TO BE HIGH. AN MRI WAS REPORTEDLY ORDERED AND THE LOGS WERE CHECKED. THE PATIENT WAS DESCRIBED AS ALIVE WITH NO INJURY AT THE TIME OF REPORT DESPITE THE PAIN AND LESS THAN 50 % THERAPY RELIEF. THE PATIENT'S PUMP WAS INTENDED TO INFUSE DILAUDID. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442073 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Other