BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4484786 · Received February 4, 2015

    Report

    Report Number
    3004209178-2015-01766
    Event Type
    Injury
    Date Received
    February 4, 2015
    Report Date
    January 14, 2015
    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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. PRODUCT ID: 8590-1, LOT# N143105, IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IN (B)(6) OF 2014, THE PUMP WAS CHECKED AND THE PATIENT FOUND OUT THAT THE MEDICATION WASN¿T GOING THROUGH THE CATHETER. THE PATIENT HAD BEEN HURTING FOR A YEAR AND A HALF. THE PATIENT HAD BEEN COMPLAINING FOR QUITE A LONG TIME THAT SHE WAS HURTING AND THE INCREASES WEREN¿T HELPING. THE PATIENT WOULD USE THE PTM (PERSONAL THERAPY MANAGER) AND IT DIDN¿T HELP. DURING THE TIME THAT SHE WAS COMPLAINING, SHE WAS PUT ON CELEBREX. NOT TOO LONG AFTER BEING PUT ON CELEBREX SHE STARTED HAVING STOMACH ISSUES, SO SHE QUIT TAKING THE CELEBREX. SINCE THEN, SHE HAD BEEN TREATED FOR STOMACH ULCERS AND STOMACH PROBLEMS. SOME DAYS SHE COULDN¿T GET UP BECAUSE OF THE STOMACH PROBLEMS AND DIARRHEA. THE PATIENT WAS SUPPOSED TO HAVE AN ¿UPPER GI¿ AND COLONOSCOPY. IN (B)(6) OF 2014, THE DEVICE SYSTEM WAS REPLACED AND SINCE THEN ALL OF HER PROBLEMS WERE GONE AND SHE WAS ON A MUCH LOWER DOSE THAN SHE HAD BEEN. THE PATIENT WAS WONDERING IF THE MEDICATION GOING INTO HER TISSUE WAS CAUSING HER STOMACH ISSUES. THE DEVICE SYSTEM HAD BEEN DELIVERING MORPHINE SINCE IMPLANT; IN (B)(6) OF 2014 DILAUDID WAS PUT IN THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79981 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Required Intervention