BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 21642901 · Received March 19, 2025

    Report

    Report Number
    3004209178-2025-04839
    Event Type
    Injury
    Date Received
    March 19, 2025
    Report Date
    September 30, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    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 SERIAL# (B)(6) IMPLANTED: (B)(6) 2017: PRODUCT TYPE CATHETER SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 8781, SERIAL/LOT #: (B)(6), UBD: 28-OCT-2024, 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

    H3: ANALYSIS OF THE CATHETER IDENTIFIED KINKS IN THE CATHETER BODY AND A HOLE IN THE CATHETER THAT IS CONSISTENT WITH REPEATED FLEXING OF THE CATHETER. ANALYSIS NOTED LEAKING WASE SEEN BY THE KINKED AREA. 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 THE PATIENT'S SYMPTOMS OF PAIN, SPASTICITY AND BULGE IN LOWER BACK AND FLUID COLLECTION WAS RESOLVED. THE SPINAL SEGMENT WOULD BE SENT TO INVESTIGATE.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, FOREIGN) REGARDING A PATIENT WHO W AS RECEIVING UNKNOWN BACLOFEN (200 MCG/ML AT 45 MCG/DAY), UNKNOWN MORPHINE DRUG (3,8 MG/ML AT 0,85 MG/DAY), AND BUPIVACAINE (1,3 MG/ML AT 0,3 MG/DAY) VIA AN IMPLANTABLE PUMP FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE PATIENT COMPLAINED OF SYMPTOM RETURNED WITH SPASTICITY AND PAIN. THE LOGS WERE READ, BUT NOT ANORMAL EVENTS WERE FOUND. THERE WERE NO KNOWN FACTORS OF ANY ENVIRO NMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. THE PUMP INFUSION DOSE WAS INCREASED BY 10%, BUT THE PATIENT CONTINUED WITH SYMPTOMS. THE ISSUE WAS NOT RESOLVED AT THE TIME OF THE REPORT. THE LOCATION OF THE PATIENT'S SYMPTOMS WERE ASKED, BUT UNKNOWN. THE PATIENT'S AGE AND WEIGHT WERE ASKED BUT WOULD NOT BE MADE AVAILABLE. THE PATIENT'S STATUS WAS ALIVE NO INJURY. THE PUMP IMPLANT DATE WAS ASKED, BUT UNKNOWN. ADDITIONAL INFORMATION RECEIVED FROM A FOREIGN HEALTH CARE PROVIDER (FOR, HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) INDICATED THAT THE PATIENT COMPLAINED OF SYMPTOM RETURN WITH SPASTICITY, PAIN AND PRESENCE OF A BULGE IN THE ANCHORAGE AREA ON THE LOWER BACK. THE PHYSICIAN PERFORMED A CONTRAST CATHETER STUDY AND A PUMP ROTOR STUDY. THESE STUDIES DIDN'T SHOW EVIDENCE FOR LEAKAGES OR A BLOCKAGE IN THE CATHETER AND ROTOR STALL IN THE PUMP. AFTER THAT, THE PHYSICIAN REVISED THE BULGE AREA AND FOUND LIQUID COLLECTION. THE PHYSICIAN DECIDED TO REPLACE ON THE SPINAL CATHETER SEGMENT BY A NEW ONE. THE EXPLANTED SEGMENT WILL BE SENT TO INVESTIGATE. ADDITIONAL INFORMATION RECEIVED FROM A FOREIGN MANUFACTURER REPRESENTATIVE (REP) INCLUDED THE CORRECTED CATHETER LOT NUMBER AND PUMP SERIAL NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688494 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention