BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 5692459 · Received June 1, 2016

    Report

    Report Number
    3004209178-2016-10692
    Event Type
    Malfunction
    Date Received
    June 1, 2016
    Date of Event
    May 6, 2016
    Report Date
    June 1, 2016
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    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 WHO WAS RECEIVING UNKNOWN BACLOFEN 300 MCG/ML AT A DOSE OF 100.42 MCG/ DAY AND SUFENTA (SUFENTANIL) 200 MCG/ML AT A DOSE OF 66.94 MCG PER DAY VIA AN IMPLANTABLE PUMP FOR NON-MALIGNANT PAIN AND FAILED BACK SURGERY SYNDROME. IT WAS REPORTED THE PATIENT'S PUMP WAS ALARMING; THE PATIENT THOUGHT SHE HEARD A SINGLE TONE ALARM ON (B)(6) 2016 THAT WAS CONFIRMED TO BE CONSISTENT WITH A PUMP ALARM. THE PATIENT HAD MISSED A SCHEDULED REFILL. THE EVENT DATE WAS INDICATED TO BE (B)(6) 2016. THE PATIENT'S HEALTHCARE PROVIDER (HCP) HAD BEEN INDICTED AND HAD CLOSED HIS PRACTICE. THE PATIENT WANTED TO KNOW AN APPROXIMATE DATE FOR WHEN HER PUMP WOULD RUN OUT OF DRUG. IT WAS DETERMINED (B)(6) 2016, 60 DAYS FROM THE PATIENT'S LAST REFILL, AND WOULD BE AN APPROXIMATE DATE. NO PATIENT SYMPTOMS WERE REPORTED. SIX DAYS LATER, ON (B)(6) 2016, IT WAS REPORTED THE PATIENT HAD DROVE TO ANOTHER HCP'S OFFICE 3.5 HOURS AWAY. THEIR PUMP WAS STILL ALARMING AT THE TIME OF THE REPORT. THE PATIENT HAD CONSULTED WITH THE HCP ON (B)(6) 2016 AND HAD BEEN SCHEDULED FOR A REFILL AT 11 A.M. ON (B)(6) 2016. THE PATIENT, HOWEVER, WAS THEN NOTIFIED THERE WAS AN ISSUE AND THEY COULDN'T REFILL THE PUMP. THE HCP HAD INITIALLY SAID THEIR PHARMACY SAID THEY COULD DO A COMPOUND. WHEN THE PATIENT WAS ON THEIR WAY TO GET THE REFILL, THEY WERE TOLD THE PHARMACY WAS REPORTEDLY WRONG. THEIR CALCULATIONS WERE WRONG AND THEY COULDN'T FIT THE MEDICATION IN THE PUMP. BECAUSE OF MIXTURE THE PATIENT HAD IN HER PUMP FROM HER PRIOR HCP, THEY COULDN'T ACCOMMODATE HER. THE HCP'S OFFICE TOLD THE PATIENT TO CALL THEIR PRIMARY CARE HCP TO GET FENTANYL PATCHES UNTIL THEY COULD FIGURE THE SITUATION OUT. THE PATIENT WAS HOWEVER 3.5 HOURS AWAY FROM HOME AND WANTED TO KNOW WHAT THEIR OPTIONS WERE BEFORE DRIVING TO A HOSPITAL. IT WAS THEN REPORTED AT THAT TIME THE BACLOFEN DOSE WAS 91.29 MCG PER DAY AND THE SUFENTANIL DOSE WAS 60.86 MCG PER DAY WITH 300 MCG/ML WITH AN UP ARROW REPORTEDLY HANDWRITTEN BY A NURSE. IT WAS THEN FURTHER REPORTED THE PATIENT'S BOYFRIEND HAD CALLED THE NEARBY HOSPITAL BUT THEY WERE NOT HELPFUL. AS A RESULT, THEY LIKELY WERE TO GO TO THE ER (EMERGENCY ROOM). NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345450 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR