BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 7130386 · Received December 19, 2017

    Report

    Report Number
    3004209178-2017-26284
    Event Type
    Malfunction
    Date Received
    December 19, 2017
    Date of Event
    November 30, 2017
    Report Date
    December 20, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00643169530119
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 8840, LOT# SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER, PHYSICIAN. PRODUCT ID: 8840, LOT# SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER, PHYSICIAN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS RECEIVING CLONIDINE AT AN UNKNOWN DOSE AND CONCENTRATION AND 25 MG/ML MORPHINE AT MINIMUM RATE VIA AN IMPLANTABLE PUMP FOR NON-MALIGNANT PAIN. IT WAS REPORTED THAT THEY PLACED A NEW PUMP AND CATHETER, PUT IN THE DRUG, AND UPDATED THE PUMP WITH WHAT THEY THOUGHT WAS THE CONCENTRATION OF THE DRUG. THEY THEN REALIZED THERE WAS A "MIX UP" SO THEY WANTED TO CONFIRM WITH THE PHARMACY WHAT CONCENTRATION THE DRUG WAS. THEY PUT THE PUMP INTO MINIMUM RATE "LAST NIGHT" [(B)(6) 2017] AFTER THEY PERFORMED A FULL SYSTEM PRIME. ON (B)(6) 2017, THEY WOULD BE UPDATING THE PROGRAMMING TO REFLECT THE TRUE CONCENTRATION AND UPDATE THE PUMP TO SIMPLE CONTINUOUS RATE. THE NEW DRUG INFORMATION WAS 25 MCG/ML CLONIDINE AT 25 MCG/DAY AND 1 MG/ML MORPHINE AT 1 MG/DAY. NO SYMPTOMS WERE REPORTED. NO FURTHER ISSUES WERE REPORTED OR ANTICIPATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED REPORTED THAT THE PATIENT¿S DOSE AND CONCENTRATION OF CLONIDINE WAS 500MCG/ML AT 24MCG/DAY AND MORPHINE AT 1.2MG/DAY. IT WAS REPORTED THAT THE WRONG DRUG CONCENTRATION WAS ENTERED. PER THE REPORTER THE PHYSICIAN¿S ORDERS WERE WRONG AND THE DRUG INFORMATION WAS ENTERED WRONG, THERE WAS A MISPRINT. THE PATIENT WOULD BE UNDERDOSED. ON 19-DEC-2017 ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS DOING FINE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910131 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20 00643169530119

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR