BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 10481684 · Received September 2, 2020

    Report

    Report Number
    3004209178-2020-15197
    Event Type
    Injury
    Date Received
    September 2, 2020
    Report Date
    July 14, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00643169508149
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3; ANALYSIS OF THE PUMP SN: (B)(6) FOUND NO ANOMALIES. ANALYSIS OF THE CATHETER SN: (B)(6)FOUND CORING IN THE CUP OF THE CONNECTOR AND MET LEAK CRITERIA PER NDHF1162-113599. H6; THE PREVIOUSLY REPORTED CODES B20, D14 AND C20 NO LONGER APPLY TO THIS EVENT AND HAVE BEEN UPDATED TO B01, D01 C07 AND C19. 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

    CONTINUATION OF D10: PRODUCT ID: 8709, SERIAL# (B)(6), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: CATHETER. 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.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE CONSUMER VIA A DEVICE MANUFACTURER REPRESENTATIVE INDICATED THAT THE PATIENT HAD INCREASED PAIN AND THAT THE SYSTEM WAS REPLACED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE CATHETER. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 8709, SERIAL/LOT #: (B)(4), UBD: 14-DEC-2006, UDI#: (B)(4). 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 AND A HEALTHCARE PROFESSIONAL (HCP) VIA A COMPANY REPRESENTATIVE REGARDING A PATIENT RECEIVING DILAUDID (10 MG/ML AT 5 MG/DAY), FENTANYL (1,500 MCG/ML AT 750 MCG/DAY), AND CLONIDINE (750 MCG/ML AT 375 MCG/DAY) VIA AN IMPLANTED PUMP. IT WAS REPORTED BY THE PATIENT THAT DURING THE LAST SEVERAL REFILLS THERE HAD BEEN A DISCREPANCY BETWEEN THE EXPECTED AND ACTUAL RESIDUAL VOLUMES. AS AN EXAMPLE, IF HIS PUMP WAS FILLED WITH 15 ML AT THE LAST REFILL AND TELEMETRY SHOWED A VOLUME OF 3 ML, THE ACTUAL VOLUME HAD BEEN THE SAME AS THE VOLUME THE PUMP HAD BEEN FILLED WITH, THE 15 ML IN THIS EXAMPLE. THE EVENT DATE WAS ASKED BUT NOTED TO BE UNKNOWN. THERE WERE NO REPORTED ENVIRONMENTAL, EXTERNAL, OR PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. THE PHYSICIAN PERFORMED A DYE STUDY TODAY ((B)(6) 2020) AND HE ALSO CHECKED THE ACTUAL RESERVOIR VOLUME. TELEMETRY SHOWED A RESERVOIR VOLUME OF 3.5 ML, BUT THE ACTUAL VOLUME WAS 13.5 ML. DURING THE DYE STUDY, THE PHYSICIAN WAS UNABLE TO ASPIRATE THE CATHETER. HOWEVER, HE DECIDED TO FLUSH DYE AND SALINE THROUGH THE CATHETER. IT WAS NOTED THAT PUSHING ANY FLUID THROUGH THE CATHETER REQUIRED EXTREME EXERTION AND THE DYE COLLECTED AROUND THE PUMP. IT WAS DETERMINED THAT THE CATHETER WAS CLOGGED AND MUST BE REPLACED. NO ACTIONS HAD YET BEEN TAKEN TO REPLACE THE CATHETER BECAUSE THE PATIENT¿S INSURANCE REQUIRED PRIOR AUTHORIZATION. ONCE THE PRIOR AUTHORIZATION WAS OBTAINED, USING THE INFORMATION ACQUIRED FROM THE DYE STUDY, THE PHYSICIAN WAS PLANNING TO MOVE AHEAD WITH A FULL CATHETER REPLACEMENT. THE ISSUE WAS NOT RESOLVED AT THE TIME OF THIS REPORT, AND IT WAS INDICATED THAT THE HCP HAD NO FURTHER INFORMATION TO PROVIDE REGARDING THE EVENT. NO PATIENT SYMPTOMS WERE REPORTED. THE PATIENT STATUS WAS REPORTED AS ¿ALIVE ¿ NO INJURY¿. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    947317 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20 00643169508149

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention