BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED III

    MDR report key: 21940944 · Received May 1, 2025

    Report

    Report Number
    3004209178-2025-07516
    Event Type
    Injury
    Date Received
    May 1, 2025
    Date of Event
    April 15, 2025
    Report Date
    May 1, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00763000597030
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID 8784 SERIAL# (B)(6) IMPLANTED: (B)(6) 2025 EXPLANTED: (B)(6) 2025 PRODUCT TYPE CATHETER. PRODUCT ID 8780 SERIAL# (B)(6) IMPLANTED: (B)(6) 2018 EXPLANTED: (B)(6) 2025 PRODUCT TYPE CATHETER. SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 8784, SERIAL/LOT #: (B)(6), UBD: 27-JUN-2026, UDI#: (B)(4) ; PRODUCT ID: 8780, SERIAL/LOT #: (B)(6), UBD: 18-APR-2020, UDI#: (B)(4). H3 - ANALYSIS OF CATHETER MODEL 8784 FOUND ¿NO SIGNIFICANT ANOMALY - CATHETER SUTURELESS CONNECTOR ¿ TEAR IN SEAL NEAR GUIDE RING ¿ DID NOT LEAK DURING TESTING.¿ ANALYSIS OF CATHETER MODEL 8780 FOUND ¿CATHETER BODY ¿ USER RELATED HOLES ¿ LEAKING SEEN DURING TESTING.¿ 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

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A COMPANY REPRESENTATIVE REGARDING A PATIENT RECEIVING GABLOFEN (2000 MCG/ML AT 273.4 MCG/DAY) VIA AN IMPLANTED PUMP. THE INDICATION FOR PUMP USE WAS INTRACTABLE SPASTICITY. IT WAS REPORTED THAT THE PATIENT¿S PUMP WAS REPLACED YESTERDAY AND THE PATIENT STAYED IN THE ICU (INTENSIVE CARE UNIT) OVERNIGHT. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED A RETURN OF THEIR SPASTICITY SYMPTOMS. THERE WERE NO KNOWN EXTERNAL FACTORS IDENTIFIED THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. THE PATIENT'S MANAGING PHYSICIAN FIRST ATTEMPTED A 5% INCREASE INMEDICATION, WHICH DID NOT RESULT IN A SIGNIFICANT CHANGE. A DYE/ROTOR STUDY WAS THEN PERFORMED TODAY, AND DYE WAS OBSERVED IN THE PUMP POCKET. THERE WAS SIGNIFICANT LEAKING OF DRUG AT THE PUMP AND CATHETER CONNECTION POINT. THE CATHETER APPEARED TO BE DISCONNECTED FROM THE PUMP OR LEAKING NEAR THE PUMP CONNECTION SITE. FOLLOWING THE DYE/ROTOR STUDY, A REVISION SURGERY WAS SCHEDULED AND COMPLETED THE SAME DAY. DURING THE PROCEDURE IT WAS NOTED THAT THE SUTURELESS CONNECTOR PORTION OF THE CATHETER WAS STILL CONNECTED TO THE PUMP, BUT THE SURGEON DESCRIBED THE CONNECTION AS "LESS STABLE THAN NORMAL," AND INDICATED THAT WHILE THE CONNECTOR WAS ABLE TO ROTATE FREELY AND RESIST PULLING, IT ALSO COULD BE OBSERVED SLIGHTLY PULLING AWAY UNDER TENSION. THE SURGEON WAS ABLE TO ASPIRATE THROUGH THE CAP (CATHETER ACCESS PORT) BUT ALSO STATED THAT THERE WAS A SIGNIFICANT AMOUNT OF AIR ENTERING THE SYRINGE AS HE DID SO. THE SUTURELESS CONNECTOR PORTION OF THE CATHETER AND COLETTE WERE REPLACED USING A NEW PUMP SEGMENT OF CATHETER WHICH WAS THEN CONNECTED TO THE REMAINDER OF THE EXISTING SPINAL SEGMENT OF THE CATHETER. THE SURGEON THEN RE-ASPIRATED THE CATHETER THROUGH THE CAP AND STATED THE FLOW WAS SIGNIFICANTLY IMPROVED WITH NO AIR ENTERING THE SYRINGE. IT WAS NOTED THAT THE HEALTHCARE PROVIDER DETERMINED THAT THE ISSUE HAD BEEN RESOLVED, AND IT WAS INDICATED THAT THE HEALTHCARE PROVIDER HAD NO FURTHER INFORMATION TO PROVIDE REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1071676 SYNCHROMED III PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8667-40 00763000597030

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female Life Threatening| H| R