BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4935531 · Received July 23, 2015

    Report

    Report Number
    3004209178-2015-13966
    Event Type
    Injury
    Date Received
    July 23, 2015
    Report Date
    July 5, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8598A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: CATHETER. PRODUCT ID 8 731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: CATHETER. PRODUCT ID 8590-9, LOT# N221023, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL. ON (B)(6) 2015, IT WAS REPORTED THAT IT WAS UNKNOWN BY THIS REPORTER WHAT OTHER MEDICATIONS THE PATIENT WAS TAKING AT THE TIME OF THE EVENT. PER THE CLINIC VISIT ON (B)(6) 2015, THE PATIENT REPORTED THAT HER KIDNEYS WERE SHUTTING DOWN AND HER HEART RATE WAS LOW; SHE HAD POSSIBLE RENAL FAILURE. THESE WERE UNRELATED TO THE PUMP. THE OVERDOSE WAS RESOLVED. THE PATIENT WAS HAVING A SIDE PORT STUDY THE NEXT DAY WITH A CONCENTRATION DECREASE.

    Description of Event or Problem · 1

    OVER THE PAST COUPLE OF DAYS, THE PATIENT HAD WEAKNESS AND SHE ¿COULDN¿T EVEN GET UP¿; THE SYMPTOMS WERE PROGRESSIVE. ON THE DATE OF THIS REPORT, THE PATIENT WAS IN THE ER (EMERGENCY ROOM) SOMNOLENT, UNRESPONSIVE, BRADYCARDIC, HYPOTENSIVE AND LOW RESPIRATIONS. THE PATIENT WAS GIVEN NARCAN AND SHE IMPROVED DRAMATICALLY. THE PATIENT WAS ADMITTED TO THE ICU (INTENSIVE CARE UNIT) FOR OBSERVATION. NOBODY AT THE FACILITY REPORTED HEARING ANY PUMP ALARMS. THEY WERE PLANNING TO TRY AND GET IN TOUCH WITH THE PATIENT¿S PUMP MANAGING PHYSICIAN, BUT DIDN¿T KNOW IF IT WOULD BE POSSIBLE ON A SUNDAY. IT WAS LATER REPORTED THAT THE PUMP WAS PROGRAMMED TO MINIMUM RATE. THE DEVICE SYSTEM WAS DELIVERING MORPHINE. THE PATIENT WAS ALSO TAKING ORAL PERCOCET AT AN UNKNOWN CONCENTRATION AND DOSE. ACCORDING TO THE ER PHYSICIAN, THE PATIENT MAY HAVE ALSO BEEN EXPERIENCING SOME KIND OF CARDIAC ISSUE, AS SHE WAS HAVING ARRHYTHMIAS. THE CAUSE OF THE EVENT AND OUTCOME WERE NOT REPORTED. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479164 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Hospitalization| L| R