BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 8003005 · Received October 24, 2018

    Report

    Report Number
    3004209178-2018-23849
    Event Type
    Malfunction
    Date Received
    October 24, 2018
    Date of Event
    October 20, 2018
    Report Date
    November 20, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00643169630505
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: A810, LOT#: UNKNOWN, PRODUCT TYPE: SOFTWARE; PRODUCT ID: 8709SC, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: CATHETER. OTHER APPLICABLE COMPONENTS ARE : PRODUCT ID: A810, LOT/SERIAL# UNKNOWN. PRODUCT TYPE: SOFTWARE. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. 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 IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES 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 REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT 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.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED VIA A HEALTHCARE PROVIDER VIA A COMPANY REPRESENTATIVE. THE COMPANY REPRESENTATIVE CLARIFIED THAT THE NAME OF THE HEALTHCARE PROVIDER THAT INITIALLY REPORTED THE EVENT AND THEIR CONTACT INFORMATION WAS UNKNOWN. THE PROGRAMMER USED AT THE TIME OF THE EVENT WAS CLARIFIED; THE CLINICIAN SOFTWARE APPLICATION WAS BEING USED. THE SOFTWARE VERSION OF THE APPLICATION THAT WAS USED WAS 1.0.7493 (THE ORIGINAL/ONLY AVAILABLE VERSION CURRENTLY AVAILABLE). IT WAS CLARIFIED THAT THE REASON FOR THE PUMP REPLACEMENT WAS A NORMAL ROUTINE REPLACEMENT DUE TO ELECTIVE REPLACEMENT INDICATOR (ERI). IT WAS NOTED THAT THERE WAS NO DEVICE ISSUE, THERAPY ISSUE, PROCEDURE ISSUE, ETC. REGARDING THE PUMP. THE CAUSE OF THE PRIMING BOLUS PROGRAMMING ERROR AND INCREASED SPASTICITY THAT OCCURRED THE FOLLOWING DAY WAS INDICATED AS BEING UNKNOWN. THE PRIMING BOLUS PROGRAMMING ERROR AND INCREASED SPASTICITY HAD BEEN RESOLVED. REGARDING IF THE PATIENT'S INCREASED SPASTICITY WAS A RESULT OF THE PRIMING BOLUS PROGRAMMING ERROR REGARDING THE BOLUS VOLUME HAVING BEEN ENTERED INCORRECTLY, AND IF UNDERDOSE/UNDERINFUSION HAD OCCURRED, IT WAS INDICATED AS BEING UNKNOWN. THE PATIENT¿S WEIGHT AT THE TIME OF THE EVENT WAS UNKNOWN.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_PROG, SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN; PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER; PRODUCT ID: NEU_UNKNOWN_PROG, SERIAL/LOT #: UNKNOWN. 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 PROVIDER (HCP) VIA A COMPANY REPRESENTATIVE REGARDING A PATIENT WHO WAS RECEIVING COMPOUNDED BACLOFEN WITH CONCENTRATION 1500 MCG/ML AT A DOSE RATE OF 1343.8 MCG/DAY VIA AN IMPLANTABLE PUMP FOR INTRACTABLE SPASTICITY. IT WAS REPORTED THAT A PRIMING BOLUS PROGRAMMING ERROR OCCURRED. THE BOLUS VOLUME WAS ENTERED INCORRECTLY. A BACK TABLE PRIME OF ONLY 0.14 ML WAS PROGRAMMED ALONG WITH THE CATHETER CLAMPED WITH DRUG IN IT AT A PUMP REPLACEMENT. THE CONCENTRATION AND DOSE WERE NOT CHANGED AT THE PUMP REPLACEMENT. THE PATIENT PRESENTED TO THE ED WITH INCREASED SPASTICITY. THE INCREASED SPASTICITY BEGAN LATE EVENING ON (B)(6) 2018. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841612 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20 00643169630505

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR