BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 18957245 · Received March 22, 2024

    Report

    Report Number
    3004209178-2024-07588
    Event Type
    Injury
    Date Received
    March 22, 2024
    Report Date
    March 22, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00763000634094
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID 8731 LOT# SERIAL# (B)(6), IMPLANTED: (B)(6) 2004, EXPLANTED: (B)(6) 2024, PRODUCT TYPE CATHETER PRO DUCT ID 8709 LOT# SERIAL# (B)(6), IMPLANTED: 2004-03-18 EXPLANTED: (B)(6) 2024 PRODUCT TYPE CATHETER SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 8731, SERIAL/LOT #: (B)(6),, UBD: 16-FEB-2006, UDI#: (B)(4) ; PRODUCT ID: 8709, SERIAL/LOT #: (B)(6), UBD: 07-FEB-2006, 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. 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 MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS RECEIV ING 10 MG/ML VIA AN IMPLANTABLE PUMP FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE PATIENT WAS SCHEDULED FOR A DYE STUDY, DURING INITIAL X-RAY ON (B)(6) 2024, IT WAS DISCOVERED THAT IMPLANTED CATHETER WAS TORN IN PUMP POCKET. THE HEALTHCARE PROVIDER (HCP) ELECTED TO REPLACE ENTIRE CATHETER. THE PATIENT EXPERIENCE SWELLING IN THE PUMP POCKET WHICH WAS FOUND TO BE MEDICATION BUILD UP FROM THE PUMP. AFTER CATHETER WAS REPLACED, PUMP WAS EMPTIED AND FILLED WITH 20 ML OF HYDROMORPHONE 2.5 MG/ML AND SET TO A RATE OF .2 MG/DAY. THERE WERE NO KNOWN ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. THE PATIENT MEDICAL HISTORY WAS ASKED BUT WILL NOT BE MADE AVAILABLE DUE TO LEGAL/CONFIDENTIAL REASON. THE PATIENT STATUS WAS ALIVE AND NO INJURY. THE ISSUE WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2562997 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20 00763000634094

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention