BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3878098 · Received June 17, 2014

    Report

    Report Number
    3004209178-2014-11701
    Event Type
    Injury
    Date Received
    June 17, 2014
    Date of Event
    November 10, 2008
    Report Date
    May 28, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, LOT # N175091004, IMPLANTED: (B)(6) 2008, PRODUCT TYPE CATHETER; PRODUCT ID 8590-1, LOT # N163649, IMPLANTED: (B)(6) 2008, PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT SAW THEIR PCP (PRIMARY CARE PHYSICIAN) FOR VAGUE COMPLAINTS. THE MANAGING PUMP HEALTH CARE PROVIDER (HCP) DID NOT DO ANY DYE STUDY. IT WAS UNKNOWN TO THE HCP HOW THE PATIENT WAS NOW DOING. THE PATIENT WAS DISCHARGED FROM THE HCP¿S PRACTICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD PROBLEMS WITH THE PUMP SINCE IMPLANT. THE FIRST YEAR AFTER THE PUMP WAS IMPLANTED, THE PATIENT GAINED (B)(6). THE PATIENT HAD BEEN SWOLLEN SINCE 6 MONTHS AFTER THE PUMP WAS IMPLANTED. WHEN THE PUMP DOSE WAS INCREASED, THE PATIENT SWELLED MORE AND MORE. THE PATIENT¿S RENAL/KIDNEY FAILURE ISSUES STARTED WHEN THE PUMP WAS IMPLANTED. THE PATIENT DID NOT HAVE KIDNEY PROBLEMS BEFORE THE PUMP WAS IMPLANTED. THE PATIENT¿S PUMP MANAGING PHYSICIAN SAID IT DID NOT HAVE ANYTHING TO DO WITH THE PUMP. THE PATIENT¿S FAMILY PHYSICIAN SAID THAT IT COULD BE THE MORPHINE CAUSING THE KIDNEY PROBLEM. THE PATIENT WAS RECENTLY DIAGNOSED WITH STAGE 3 KIDNEY DISEASE. THE PATIENT STATED THAT SHE LIKED THE PUMP IN THE BEGINNING BECAUSE IT TOOK THE PAIN AWAY, BUT SHE DID NOT LIKE THE SIDE EFFECTS. THE PATIENT ALSO HAD CONSTIPATION AROUND THE TIME THE PUMP WAS IMPLANTED. CLONIDINE WAS ADDED TO THE PUMP 6 MONTHS TO A YEAR AGO. THE PATIENT ITCHED AND WAS UNCOMFORTABLE. THE PATIENT ALSO HAD SWELLING AND WAS HAVING SWEATS. THE PATIENT HAD BEEN DISMISSED BY HER CURRENT PUMP MANAGING PHYSICIAN AND WAS LOOKING FOR ANOTHER PHYSICIAN TO REFILL THE PUMP. THE DEVICE SYSTEM WAS DELIVERING MORPHINE (4 MG/ML AT 0.6720 MG/DAY) AND CLONIDINE (100 MCG/ML AT 16.80 MCG/DAY). ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355881 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR Other