BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2182207-2021-01645

    MDR report key: 12523118 · Received September 23, 2021

    Report

    Report Number
    2182207-2021-01645
    Event Type
    Malfunction
    Date Received
    September 23, 2021
    Date of Event
    September 22, 2021
    Report Date
    November 3, 2021
    Product Code
    LKK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. 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 · 0

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

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) INDICATED THE PATIENT CAME BACK THE NEXT DAY FOR REPROGRAMMING AND THE ISSUE WAS RESOLVED. THE SERIAL NUMBER OF THE CLINICIAN PROGRAMMER WAS NOT PROVIDED.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED BY A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT WHO WAS RECEIVING BACLOFEN (1000 MCG/ML AT 350.8 MCG/DAY) VIA IMPLANTABLE INFUSION PUMP. IT WAS REPORTED THAT THE PATIENT WAS IN FOR A PUMP REFILL ON (B)(6) 2021. THE DRUG WAS CHANGED FROM 1000 MCG/ML TO 2000 MCG/ML BACLO FEN BUT THE PUMP WAS NOT UPDATED WITH THE NEW DRUG CONCENTRATION. TECHNICAL SERVICES REVIEWED THAT A BRIDGE BOLUS WOULD TYPICALLY RUN FOR 28 HOURS AND 40 MINUTES (.220 ML CATHETER VOLUME + .199 ML PUMP TUBING = 0.419 X 1000 = 419 MCG/350.8 = 28 HOURS AND 40 MINUTES). AN OPTION WAS REVIEWED TO BRING THE PATIENT BACK ON (B)(6) 2021 TO UPDATE THE PUMP TO THE CORRECT DRUG CONCENTRATION AND PROGRAM THE ADVANCED MODE BRIDGE BOLUS IF NEEDED. THE HCP WILL CONTACT THE PATIENT TO COME BACK TO THE OFFICE ON (B)(6) 2021 TO HAVE THE PUMP UPDATED. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. NO SYMPTOMS/PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1421476 LKK NEU_UNKNOWN_PROG

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR