BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 21792907 · Received April 7, 2025

    Report

    Report Number
    2182207-2025-00913
    Event Type
    Injury
    Date Received
    April 7, 2025
    Date of Event
    March 31, 2025
    Report Date
    June 19, 2025
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID: 8781, EXPLANTED: ON (B)(6) 2025, PRODUCT TYPE: CATHETER. SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 8781. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM A FOREIGN HEALTH CARE PROVIDER (FOR, HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) INDICATED THAT IMPLANT DATE OF THE PUMP THAT WAS EXPLANTED ON (B)(6) 2025 WAS 10/2018. THE SERIAL NUMBER OF THE PUMP WAS PROVIDED IN ADDITION TO THE GENDER AND WEIGHT OF THE PATIENT. THE WEIGHT OF THE PATIENT AND THE SERIAL/LOT NUMBER OF THE CATHETER WAS NOT PROVIDED. HOWEVER, THE IMPLANTED VOLUME (0.274 ML) AND IMPLANTED LENGTH (124.7 CM) WAS PROVIDED. THE PATIENT'S MEDICAL HISTORY INCLUDED SECONDARY PROGRESSIVE MULTIPLE SCLEROSIS (MS) AND A LEFT HIP FRACTURE IN OCTOBER 2020. IT WAS STATED THAT A PROGRESSIVE DOSE INCREASE REQUIRED MINIMAL IN 2022-2023 AND SIGNIFICANT SINCE FEBRUARY 2024 DUE TO INCREASED SPASTICITY, WHICH LED TO DETERIORATING FUNCTION. THERE WAS EXCESSIVE WEAKNESS IN JULY WITH NEED TO RETURN TO FEBRUARY DOSE WITH NO RETURN TO BASELINE FUNCTION AND MS PROGRESSION WAS AS SUSPECTED. FOLLOWING THE FALL IN DECEMBER WITH INCREASED PAIN AND SPASMS, INTRATHECAL BACLOFEN (ITB) DOSE WAS INCREASED AGAIN AND GIVEN. IN ADDITIONAL THE ABOVE-DESCRIBED CHANGES IN RESPONSE TO ITB AN EARLY PUMP REPLACEMENT WAS SCHEDULED (ANYWAY DUE IN A FEW MONTHS). THE FOLLOWING DATA WAS PROVIDED: 2024: (B)(6) 2024: 99 MCG/DAY (FLEX) - 108.9 MCG/DAY (FLEX) (B)(6) 2024: 103.8 MCG/DAY (FLEX) ­ - 99 MCG/DAY (FLEX) (B)(6) 2024: 116.8 MCG/DAY (FLEX) - 103.8 MCG/DAY (FLEX) (B)(6) 2024: 99 MCG/DAY (FLEX) - 116.8 MCG/DAY (FLEX) (B)(6) 2024: 82 MCG/DAY (FLEX) - 99 MCG/DAY (FLEX) (B)(6) 2024: 74.9MCG/DAY (SC) - 82 MCG/DAY (FLEX)(B)(6) 2023: 74.9 MCG/DAY (SC) - 74.9 MCG/DAY (SC) (B)(6) 2023: 70.8 MCG/DAY (FLEX) - 74.9 MCG/DAY (SC) (B)(6) 2022: 67.3 MCG/DAY (FLEX) - 70.8 MCG/DAY (SC) 2021 (B)(6) 201: 67.3 MCG/DAY (FLEX) - 67.3 MCG/DAY (FLEX) 2018: STARTING DOSE: UNKNOWN AFTER FULL DEVICE REPLACEMENT, ITB DOSE HAD TO BE REDUCED DUE TO EXCESSIVE MUSCLE RELAXATION. FUNCTIONAL LEVEL REMAINED SOMEWHAT AFFECTED, ALSO IN LIGHT OF UNDERLYING PROGRESSIVE NEUROLOGICAL CONDITION. THERE WAS A NEW PUMP AND FULL CATHETER REPLACEMENT. THE STARTING DOSE ON (B)(6) 2025 WAS 65 MCG/DAY (FLEX) AND ON (B)(6) 2025 IT WAS UPDATED TO 42.06 MCG/DAY SIMPLE CONTINUOUS.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, FOREIGN) REGARDING A PATIENT WHO W AS RECEIVING AN UNKNOWN DRUG VIA AN IMPLANTABLE PUMP. IT WAS REPORTED THAT PATIENTS HAD A PUMP REPLACEMENT FOR BATTERY END OF LIFE (EOL) ON MONDAY (ON (B)(6) 2025), AND THE CATHETER APPEARED NOT PATENT AS THERE WAS NO FLUID DRIPPING ONCE DISCONNECTED FROM PUMP. THERE WAS NO EVIDENCE OF MORE DISTAL DISCONNECTION OR BREAKS FOR WHAT COULD BE SEEN. IT WAS FURTHER REPORTED THAT THE PATIENT ALSO HAS RECENT HISTORY OF INCREASED SPASTICITY AFTER A FALL, WHICH IS ALSO IN CONTEXT OF MORE LONGSTANDING SLOW PROGRESSION OF THEIR NEUROLOGICAL CONDITION, FOR WHICH WE IN FACT PUSHED FOR A SLIGHTLY EARLIER REPLACEMENT. THE PUMP AND CATHETER WERE REPLACED. THE COMPLETE CATHETER WAS EXPLANTED AND WAS TO BE RETURNED TO THE MANUFACTURER. THEY SAVED THE CATHETER AND WERE REQUESTING THAT IT BE ANALYZED TO ASCERTAIN THE ACTUAL ISSUE AND IF THIS COULD BE LINKED TO THE FALL OR SOMETHING ELSE. THE PATIENT WAS WITHOUT INJURY REGARDING THEIR STATUS AS OF ON (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605676 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Unknown Required Intervention