BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 8074581 · Received November 15, 2018

    Report

    Report Number
    3004209178-2018-25520
    Event Type
    Injury
    Date Received
    November 15, 2018
    Report Date
    December 6, 2018
    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
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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

    2018-11-14 MPXR 576282 (REP): INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT RECEIVING DILAUDID 20 MG/ML FOR A TOTAL DOSE OF VIA AN IMPLANTABLE PUMP FOR 3.4 MG/DAY VIA AN IMPLANTABLE PUMP FOR SPINAL PAIN. IT WAS REPORTED THE PATIENT COMPLAINED THE PUMP WAS NOT WORKING. IT WAS NOTED THAT THERE WERE NO ISSUES REPORTED AS TO WHY THIS COULD HAVE HAPPENED. DIAGNOSTICS/TROUBLESHOOTING INCLUDED A DYE STUDY (UNKNOWN DATE) WAS PERFORMED AND THE HEALTHCARE PROFESSIONAL (HCP) WAS NOT SUCCESSFUL IN ASPIRATING THE CATHETER. THE HCP TRIED TO ASPIRATE THE CATHETER IN THE OPERATING ROOM AND WAS NOT ABLE TO GET CEREBROSPINAL FLUID (CSF). IT WAS NOTED WHEN THE HCP SWITCHED OUT THE PUMP SEGMENT AND 1 CM OF THE SPINAL SEGMENT, WHICH WAS TWIRLED, THEY WERE ABLE TO GET CSF. THE PUMP SEGMENT WAS REMOVED ALONG WITH 1CM OF THE SPINAL SEGMENT AND REPLACED WITH ANOTHER PUMP SEGMENT ON (B)(6) 2018. THE PART OF THE CATHETER THAT WAS REMOVED WAS DISCARDED AND WOULD NOT BE RETURNED. IT WAS NOTED THAT THE ISSUE WAS RESOLVED AT TIME OF REPORT, AND THE PATIENT'S STATUS AT TIME OF REPORT WAS ALIVE-NO INJURY. THE PATIENT'S WEIGHT WAS ASKED, AND UNKNOWN. THE PATIENT'S MEDICAL HISTORY WAS ASKED AND WILL NOT BE MADE AVAILABLE. THE EVENT DATE WAS ASKED, BUT UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED. 2018-11-29 E1 (REP, CON): ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). THE INITIAL REPORTER WAS THE CONSUMER. NO FURTHER COMPLICATIONS WERE REPORTED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8780, SERIAL #: (B)(4), IMPLANTED: (B)(6) 2016, EXPLANTED: (B)(6) 2018, PRODUCT TYPE: CATHETER. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 8780, SERIAL/LOT #: (B)(4), UBD: 10-AUG-2018, 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 MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT RECEIVING DILAUDID 20 MG/ML FOR A TOTAL DOSE OF VIA AN IMPLANTABLE PUMP FOR 3.4 MG/DAY VIA AN IMPLANTABLE PUMP FOR SPINAL PAIN. IT WAS REPORTED THE PATIENT COMPLAINED THE PUMP WAS NOT WORKING. IT WAS NOTED THAT THERE WERE NO ISSUES REPORTED AS TO WHY THIS COULD HAVE HAPPENED. DIAGNOSTICS/TROUBLESHOOTING INCLUDED A DYE STUDY (UNKNOWN DATE) WAS PERFORMED AND THE HEALTHCARE PROFESSIONAL (HCP) WAS NOT SUCCESSFUL IN ASPIRATING THE CATHETER. THE HCP TRIED TO ASPIRATE THE CATHETER IN THE OPERATING ROOM AND WAS NOT ABLE TO GET CEREBROSPINAL FLUID (CSF). IT WAS NOTED WHEN THE HCP SWITCHED OUT THE PUMP SEGMENT AND 1 CM OF THE SPINAL SEGMENT, WHICH WAS TWIRLED; THEY WERE ABLE TO GET CSF. THE PUMP SEGMENT WAS REMOVED ALONG WITH 1CM OF THE SPINAL SEGMENT AND REPLACED WITH ANOTHER PUMP SEGMENT ON (B)(6) 2018. THE PART OF THE CATHETER THAT WAS REMOVED WAS DISCARDED AND WOULD NOT BE RETURNED. IT WAS NOTED THAT THE ISSUE WAS RESOLVED AT TIME OF REPORT, AND THE PATIENT'S STATUS AT TIME OF REPORT WAS ALIVE-NO INJURY. THE PATIENT'S WEIGHT WAS ASKED, AND UNKNOWN. THE PATIENT'S MEDICAL HISTORY WAS ASKED AND WILL NOT BE MADE AVAILABLE. THE EVENT DATE WAS ASKED, BUT UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    915349 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20 00643169508149

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention