BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 9225876 · Received October 23, 2019

    Report

    Report Number
    3007566237-2019-02190
    Event Type
    Injury
    Date Received
    October 23, 2019
    Report Date
    October 23, 2019
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT RECEIVING AN UNKNOWN DOSE AND CONCENTRATION OF BACLOFEN AND AN UNKNOWN CONCENTRATION OF MORPHINE AT 5.27 MG/DAY VIA AN IMPLANTABLE PUMP FOR NON-MALIGNANT PAIN AND CHRONIC LOW BACK PAIN. IT WAS REPORTED THE PATIENT'S PUMP HAD BURNED OUT THREE TIMES IN ONE WEEK. THE PATIENT STATED THEY WENT TO THE HOSPITAL FOR SAME DAY SURGERY TO HAVE THEIR PUMP REPLACED THAT FRIDAY. THE PATIENT WENT HOME THAT FRIDAY EVENING. THAT SUNDAY MORNING AT 1:00 AM THEY COULD SMELL SOMETHING LIKE "BURNING RUBBER," HAD A FEVER, COULD NOT LIFT THEIR HEAD OR EAT ANYTHING AND WAS "DEATHLY SICK". THE PATIENT STATED THEY COULD NOT STAND THE SYMPTOMS SO SHE WAS ADMITTED TO THE HOSPITAL. THE PATIENT STATED THE PUMP HAD "BURNED OUT/MALFUNCTIONED," SO THE DOCTOR PUT ANOTHER PUMP IN AND IT HAPPENED AGAIN. THE PUMP WAS ADJUSTED TO MAKE SURE IT WOULD WORK, BUT THAT PUMP WENT OUT, TOO. THE PATIENT STATED THE PUMP WAS NOT ACCEPTING THE PATIENT. THE PATIENT STATED THE CATHETER AND "WIRING" HAD BEEN IN PLACE SINCE THE FIRST PUMP SO THEN EVERYTHING WAS REPLACED AND THEN EVERYTHING WAS FINE AFTER THAT, PER THE PATIENT. IT WAS REPORTED THIS OCCURRED THE PAST SUMMER, IN (B)(6) 2018. PER DEVICE REGISTRATION, THE PATIENT'S PUMP (PUMP MODEL NUMBER 8637-20 SERIAL NUMBER (B)(4)) WAS REPLACED ON AUGUST 17, 2018 (WITH PUMP MODEL NUMBER 8637-20 SERIAL NUMBER (B)(4)), AND THE PREVIOUS PUMP REPLACEMENT OCCURRED ON (B)(6) 2012 (WHEN PUMP MODEL NUMBER 863720 SERIAL NUMBER (B)(4) WAS REPLACED WITH PUMP MODEL NUMBER 8637-20 SERIAL NUMBER (B)(4)). THE PATIENT STATED THEY WERE RECEIVING A DRUG COCKTAIL AT THIS TIME: BACLOFEN, MORPHINE, AND A NERVE MEDICATION. THE PATIENT SAID THEIR DOCTOR TOLD THEM IT WOULD WORK BETTER WITH JUST MORPHINE AT 5.27 MG/DAY. THE PATIENT STATED THE DOSING WAS UP HIGHER BUT THE DOCTOR WAS BRING THE PATIENT'S DOSE DOWN SLOW SINCE THE DRUG LAWS CHANGED WITH PAINOPIATES. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1018759 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention