BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 23522548 · Received November 11, 2025

    Report

    Report Number
    3004209178-2025-19205
    Event Type
    Injury
    Date Received
    November 11, 2025
    Date of Event
    October 19, 2025
    Report Date
    December 30, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00763000634100
    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 8598A SERIAL# (B)(6). IMPLANTED: (B)(6) 2017: PRODUCT TYPE CATHETER PRODUCT ID A820. SERIAL# UNKNOWN: PRODUCT TYPE SOFTWARE SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 8598A, SERIAL/LOT #: (B)(6), UBD: 02-JUN-2018, 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.

    Additional Manufacturer Narrative · 0

    REVIEW OF THIS MDR AND/OR ADDITIONAL INFORMATION RECEIVED SHOWS THAT THERE IS NO INFORMATION TO REASONABLY SUGGEST THAT THE DEVICE IN THIS REPORT MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE IN THIS REPORT HAS MALFUNCTIONED. THEREFORE, THIS EVENT DID NOT AND DOES NOT MEET THE REPORTING REQUIREMENTS STIPULATED IN 21 CFR 803. NOTE THAT THE H6 CODES HAVE BEEN UPDATED TO REFLECT THE NEW INFORMATION AND B2 NO LONGER HAS AN OUTCOME ATTRIBUTED TO AN ADVERSE EVENT. 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 AND CONSUMER REGARDING A PATIENT WITH AN IMPLANTABLE PUMP CONTAINING MORPHINE (U NKNOWN) FOR SPINAL PAIN INDICATIONS. IT WAS REPORTED THAT THE PATIENT STATED THEY BELIEVE THE PUMP WAS NOT WORKING BECAUSE THEY ATTEMPTED TO GET A BOLUS AND IT DID NOT GO THROUGH. THE HEALTHCARE PROVIDER (HCP) CONFIRMED THAT THERE WERE NO ALERTS ON THE HANDSET. IT WAS REPORTED THAT PATIENT HAD AN INCREASE IN PAIN, NAUSEA, WEAKNESS AND SHAKING. PATIENT IS CURRENTLY IN THE HOSPITAL. CALLER STATED THE HCP HAS "PULLED" TWO SAMPLES OF CEREBROSPINAL FLUID (CSF) THAT WERE INFECTED, DARK YELLOW AND CLOUDY. THE HCP HAS TESTED THE WHITE CELL, AND OTHER TESTS BUT CALLER DOESN'T BELIEVE THEY HAVE INTERROGATED THE PUMP OR TESTED THE CATHETER. CALLER STATED THE HCP CONSIDERED THE PATIENT MAY HAVE MENINGITIS. PATIENT STATED THEY THINK THE CATHETER WAS KINKED. PATIENT AND CALLER STATED THE PATIENT'S BLOOD PRESSURE IS VERY HIGH. 246/109. 240/130. CALLER WAS REDIRECTED TO PATIENTS HCP TO ADDRESS MEDICAL CONCERNS.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER (HCP). WHEN ASKED ABOUT THE CAUSE OF THE PATIENT TRYING TO BOLUS AND IT NOT GOING THROUGH, THE HCP REPORTED THIS WAS NOT THE CASE AND THAT LOGS REVEALED NORMAL PERSONAL THERAPY MANAGER (PTM) FUNCTION. THE HCP STATED QUESTIONS RELATING TO THE SOFTWARE VERSION, ACTIONS AND RESOLUTION FOR THE BOLUS ISSUE, CLARIFICATION REGARDING THE REPORT THE CATHETER WAS KINKED, CAUSE OF A CATHETER KINK, DIAGNOSTICS AND ACTIONS REGARDING THE CATHETER KINK AND THE CATHETER KINK RESOLUTION WERE NOT APPLICABLE. THE HCP REPORTED THAT THE CAUSE OF THE PATIENT'S CURRENT HOSPITALIZATION IS SEPSIS THAT IS 'UNRELATED TO THE HARDWARE'. THE PATIENT'S SYMPTOMS OF PAIN, NAUSEA, WEAKNESS, SHAKING, HIGH BLOOD PRESSURE, AND CEREBRAL SPINAL FLUID LOOKING DARK YELLOW AND CLOUDY WERE REPORTED AS BEING RELATED TO THE MENINGITIS. IT WAS REPORTED THAT ACTIONS TAKEN TO RESOLVE THE MENINGITIS AND ADDITIONAL SYMPTOMS WAS INPATIENT CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2525241 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40 00763000634100

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Required Intervention "SEE H11....".