BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 11045728 · Received December 21, 2020

    Report

    Report Number
    3004209178-2020-22282
    Event Type
    Malfunction
    Date Received
    December 21, 2020
    Report Date
    December 21, 2020
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00643169984219
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 MORPHINE VIA AN IMPLANTED PUMP. THE PATIENT WAS CALLING TO REVIEW RECALL INFORMATION REGARDING THE PUMP. PER THE PATIENT, SHE FELT THAT THE PUMP WAS INTERMITTENTLY NOT WORKING. SHE STATED THAT SHE FOUND ONLINE THAT HER PUMP¿S SERIAL NUMBER WAS NOT INCLUDED IN A RECALL, BUT SHE WANTED TO KNOW SOME OF THE SYMPTOMS THAT ONE MIGHT EXPERIENCE. WHEN ASKED WHEN THE ISSUE BEGAN, THE PATIENT STATED, ¿IT HAS BEEN QUITE A WHILE AND IT IS INTERMITTENT¿. SHE STATED THAT SHE FELT THAT SHE WAS NOT GETTING THE MEDICATION ¿ALTHOUGH THE BIGGEST AMOUNT OF MEDICATION DIFFERENCE WAS LIKE, AH I CAN'T REMEMBER, POINT OH I DON'T REMEMBER IT ONLY HOLDS 20 SO I GUESS IT WAS LIKE 5". SHE STATED, "MY PAIN IS SO SEVERE IT FEELS LIKE ITS NOT WORKING". THE PATIENT THEN STATED, "MAYBE IT IS, AND THIS IS JUST MY PAIN". SHE STATED THE FEELING WAS INTERMITTENT AND IT GOT REALLY BAD AND THEN IT GOT BETTER ¿NOT BETTER, BUT YA KNOW BETTER". PER THE PATIENT, THE PUMP WAS NOT ALARMING. SHE STATED THAT HER PUMP ALARMED BEFORE WHEN SHE HAD AN MRI AND THE PUMP WOULD ALARM WHEN SHE GOT TO 2 ML OF MORPHINE LEFT IN THE PUMP. THE PATIENT ALSO STATED THAT SOMETIMES WHEN SHE TRIES TO BOLUS ¿THE PRINTOUT SHOWS SHE PRESSED THE BUTTON 2X WHICH CANCELLED THE BOLUS REQUEST AND WHEN IT DOES FUNNY THING SHE SENDS A PICTURE OF THE SCREEN TO HER HOME NURSE¿. THE PTM PROGRAMMING WAS ¿.0315 MG BOLUS, .6174 PER DAY, 4X DAY, 1X 180M, 4X24HR, BOLUS DURATION 1 MIN, 4.4MG, .6714 MG, 0.0280 MG/HOUR, MAX DAILY DOSE .7955 MG/DAY¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1516917 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20 00643169984219

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR