BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 6136214 · Received November 30, 2016

    Report

    Report Number
    3004209178-2016-24912
    Event Type
    Malfunction
    Date Received
    November 30, 2016
    Date of Event
    October 28, 2016
    Report Date
    March 31, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00643169100824
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 8784, SERIAL # (B)(4), IMPLANTED: (B)(6) 2015, PRODUCT TYPE CATHETER; PRODUCT ID 8782, SERIAL # (B)(4), IMPLANTED: (B)(6) 2015, PRODUCT TYPE CATHETER.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM A HEALTHCARE PROVIDER (HCP) INDICATED THE THINKING THE "LEAD" HAD MOVED WAS THE PATIENT'S OPINION AND HAD NOT BEEN PROVEN. IT WAS NOTED NO RECENT IMAGING OR CATHETER DYE STUDY HAD BEEN COMPLETED. THE HCP WAS CONSIDERING DECREASING THE BUPIVACAINE DOSE IN THE FUTURE. THE CAUSE OF THE NUMBNESS FOLLOWING PTM ACTIVATIONS AND THE LEAD ISSUES WAS NOT DETERMINED AND HAD NOT BEEN RESOLVED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT RECEIVING FENTANYL (UNKNOWN CONCENTRATION AT 999/1218 MCG/DAY), DILAUDID (UNKNOWN CONCENTRATION AT .899/1.0961 MG/DAY), AND BUPIVACAINE (UNKNOWN CONCENTRATION AT 7.84/9.56 MG/DAY) VIA AN IMPLANTABLE INFUSION PUMP. THE INDICATION FOR USE WAS NOTED AS SPINAL PAIN. IT WAS REPORTED THE PATIENT EXPERIENCED NUMBNESS WHEN USING THE PERSONAL THERAPY MANAGER (PTM). THE PATIENT NOTED THE SKIN AROUND THE PUMP AND ALL THE WAY TO HER BELLY BUTTON WHEN SHE ADMINISTERS A PTM BOLUS. THE PATIENT NOTED IT WAS A LARGE AREA ON BOTH SIDES OF THE PUMP AND THE PUMP WAS PLACED IN THE LEFT BUTTOCKS. THE PATIENT THOUGHT THE "LEAD" HAD MOVED. IT WAS NOTED THE HYDROMORPHONE WOULD BE INCREASED ON (B)(6) 2016. THE PATIENT HAD A RECENT THIRTY POUND WEIGHT LOSS. THE PATIENT NOTED ITS SCARY WHEN THAT HAPPENS BECAUSE SHE COULDN'T FEEL ANYTHING IN THAT AREA. THE PATIENT CALLED THE HEALTHCARE PROVIDER (HCP) AND THERE WERE NO PUMP NURSES TO HELP HER. THE HCP TOLD HER TO GO THE EMERGENCY ROOM IF SHE WAS VERY CONCERNED. THE PATIENT NOTED THAT SHE WAS ALMOST OUT OF ORAL MEDICATIONS. THE PATIENT NOTED THAT THIS WAS HAPPENING TWO WEEKS AGO BUT IT HAD GOTTEN WORSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784962 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40 00643169100824

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR