BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 21036041 · Received December 30, 2024

    Report

    Report Number
    3004209178-2024-24241
    Event Type
    Malfunction
    Date Received
    December 30, 2024
    Date of Event
    November 28, 2023
    Report Date
    February 6, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID 8785 LOT# N770205, IMPLANTED: (B)(6) 2023, PRODUCT TYPE CATHETER SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 8785, SERIAL/LOT #: (B)(6), UBD: 27-NOV-2019, UDI#: (B)(4), 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID 8785, SERIAL/LOT#(B)(6), IMPLANTED: (B)(6) 2018, PRODUCT TYPE: CATHETER. 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 FOREIGN HEALTHCARE PROVIDER (HCP) VIA A DISTRIBUTER (DIST) REGARDING A PATIENT RECEIVING GABALON AT A DOSE RATE OF 27 MCG/DAY VIA IMPLANTED INFUSION PUMP FOR DEGENERATIVE DISEASE. IT WAS REPORTED THAT THE FOLLOWING ABNORMAL VARIABILITY RATES REGARDING PUMP RESERVOIR VOLUME DISCREPANCIES OCCURRED: (B)(6) 2023- ABNORMAL VARIABILITY RATE OF -52% DURING INITIAL REFILL AFTER PUMP REPLACEMENT, (B)(6) 2024- ABNORMAL VARIABILITY RATE OF -52% DURING REFILL, (B)(6) 2024 - ABNORMAL VARIABILITY RATE OF -72% DURING REFILL, (B)(6) 2024- ABNORMAL VARIABILITY OF -47% DURING REFILL ON, AND (B)(6) 2024- ABNORMAL VARIABILITY RATE OF -39% DURING REFILL ON. IT WAS FURTHER REPORTED THAT ON (B)(6) PUMP OPERABILITY WAS FOUND TO BE NORMAL DURING THE PUMP ROLLER TEST; HOWEVER, DRUG ASPIRATION WAS NOT POSSIBLE DURING AN ATTEMPTED CATHETER CONTRAST STUDY. CONTRAST AGENT INJECTION WAS ALSO NOT POSSIBLE. THE OUTCOME OF THE EVENT WAS UNKNOWN. REGARDING ETIOLOGY, THE RELATIONSHIP OF THE ABNORMAL VARIABILITY RATE TO DRUG (GABALON) WAS UNRELATED AND THEY SUSPECTED A CATHETER PROBLEM DUE TO THE INABILITY TO ASPIRATE. NO PATIENT SYMPTOM WAS REPORTED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM A FOREIGN HEALTHCARE PROVIDER VIA A COMPANY REPRESENTATIVE. THE IMPLANT DATE OF THE CATHETER WAS CLARIFIED AS (B)(6) 2018. THE PATIENT HAD NOT EXPERIENCED ANY SIGNS OR SYMPTOMS AS A RESULT OF THE ISSUE. ACTIONS SINCE TAKEN TO RESOLVE THE PUMP RESERVOIR VOLUME DISCREPANCIES AND INABILITY TO ASPIRATE OR INJECT THE CATHETER WERE UNKNOWN. THE CAUSE OF THE SUSPECTED CATHETER PROBLEM / PUMP RESERVOIR VOLUME DISCREPANCIES AND INABILITY TO ASPIRATE OR INJECT THE CATHETER WAS UNKNOWN. IT WAS UNKNOWN IF THE SUSPECTED CATHETER ISSUE / PUMP RESERVOIR VOLUME DISCREPANCIES AND INABILITY TO ASPIRATE OR INJECT THE CATHETER WERE SINCE RESOLVED. THE IMPLANTED DEVICES WERE STILL IN USED AND THEREFORE WOULD NOT BE RETURNED TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2420253 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11....| SEE H11....