BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3072823 · Received April 23, 2013

    Report

    Report Number
    3004209178-2013-06743
    Event Type
    Injury
    Date Received
    April 23, 2013
    Report Date
    March 27, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8711, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD INCREASED TIGHTNESS THAT STARTED APPROXIMATELY IN NOVEMBER AND THE SYMPTOMS WOULD COME AND GO. THE SITE OVER THE PUMP WAS SWOLLEN FOR APPROXIMATELY THE PAST WEEK. A CATHETER ACCESS PORT (CAP) ASPIRATION AND DYE STUDY WERE PERFORMED AND THE RESULTS WERE REPORTED AS "EVERYTHING SEEMED OKAY." IT WAS NOTED THAT THE LAST HEALTH CARE PROVIDER (HCP) THAT EXAMINED THE PATIENT WAS NERVOUS ABOUT FILLING THE PUMP DUE TO THE SWELLING, AND THOUGHT THERE WAS SOME KIND OF DISCONNECT. AN X-RAY WAS PERFORMED AND IT WAS NOTED IT LOOKED "OKAY". THERE WAS TRANSLUCENCY NOTED WHERE THE CATHETERS CONNECTED, AND AFTER THE TRANSLUCENCY THE CATHETER LOOKED A LITTLE "BLURRED AND DIFFERENT"; HOWEVER, THE PHYSICIAN BELIEVED IT MAY HAVE BEEN DUE TO THE WAY IT WAS JOINED. THE PHYSICIAN STATED IT LOOKED LIKE A SEROMA. AN ABDOMINAL BINDER WAS RECOMMENDED TO HELP WITH THE SWELLING. THE PUMP WAS DELIVERING GABLOFEN. IT WAS LATER REPORTED THAT THE EVENT WAS DUE TO DRUG-EFFECTS. IT WAS NOTED THE PATIENT SEEMED TO BE IN WITHDRAWAL, AND HAD EXPERIENCED INCREASED TIGHTNESS IN THE LEGS. A CAP ASPIRATION UNDER FLUOROSCOPY WITH DYE WAS PERFORMED ON (B)(6) 2013, WHICH SHOWED NORMAL FLOW TO THE INTRATHECAL SPACE. AN X-RAY WAS INDICATED TO HAVE BEEN DONE ON (B)(6) 2013. IT WAS ALSO NOTED THAT A BOLUS WAS GIVEN AND PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174899 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00014 YR Other