BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3971849 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-13796
    Event Type
    Injury
    Date Received
    July 31, 2014
    Report Date
    July 7, 2014
    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
    AK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8780, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE CATHETER; PRODUCT ID 8835, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT GOT AN INFECTION BECAUSE OF A NURSE WHO COULDN¿T FIND THE PORT ON THE PUMP AND CONTINUED TO LAY THE NEEDLE DOWN ON A TABLE WITHOUT RECAPPING IT. IT HAPPENED QUITE A FEW YEARS AGO. IT WAS NOTED THAT THE PATIENT HAD AN AUTOIMMUNE DISEASE. THE INFECTION WAS DESCRIBED AS ¿VERY SUDDEN.¿ THE PATIENT HAD DILAUDID AND SOMETHING ELSE IN THE PUMP AT THAT TIME. ADDITIONAL INFORMATION RECEIVED THAT¿S CONFLICTING PREVIOUSLY REPORTED INFORMATION. IT WAS NOTED THAT THE PATIENT DID NOT HAVE ANY INFECTION RELATED TO THEIR INTRATHECAL IMPLANTED PUMP. THE PATIENT WAS LAST SEEN IN THE OFFICE ON (B)(6) 2014. THERE WERE NO PRIOR REPORTED COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446844 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Other