BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED III

    MDR report key: 22522248 · Received July 16, 2025

    Report

    Report Number
    3004209178-2025-12134
    Event Type
    Injury
    Date Received
    July 16, 2025
    Report Date
    July 16, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00763000597023
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID 8780 LOT# SERIAL# (B)(6) IMPLANTED: (B)(6) 2024 EXPLANTED: (B)(6) 2024 PRODUCT TYPE CATHETER SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 8780, SERIAL/LOT #: (B)(6), UBD: 26-JAN-2026, 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 THE HEALTHCARE PROVIDER (HCP) VIA THE COMPANY REPRESENTATIVE (REP) REGARDING A PATIENT RECEIVING INTRATHECAL MORPHINE 3MG/ML AT 0.4126MG/DAY SIMPLE CONTINUOUS WITH PERSONAL THERAPY MANAGER (PTM) ALLOWING FOR MAX 24 HOUR DAILY DOSE OF 0.6658MG/DAY VIA AN IMPLANTABLE PUMP. IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AND THE SYSTEM WAS EXPLANTED. ON (B)(6) 2025 PATIENT HAD NEW PUMP AND CATHETER IMPLANTED. THE ISSUE RESOLVED AT THE TIME OF THIS REPORT. THEPATIENT'S MEDICAL HISTORY WAS THE FOLLOWING: MEDICAL HISTORY: HTN, GERD, INSOMNIA, LUMBAR INTERVERTEBRAL DISC DISEASE, CHRONIC PAIN SYNDROME, VITAMIN D DEFICIENCY, HYDRONEPHROSIS, HLD, MRSA, OSTEOPOROSIS, 09/1980 TITAN NUCLEAR MISSILE SILO EXPLOSIONSEVERE INJURY WITH SKIN GRAFTING, ORIF WITH PINS, SEVERED LEFT ACHILLES TENDON REPAIR, LUMBAR SACRAL SURGERY X8, SPINAL CORD STIMULATOR, L4 SCREW REMOVAL, FOREMENOTOMY, LAMINECTOMY, URETHERAL RE IMPLEMENTATION WITH SOAS HITCH AND BAORIFLAP, RIGHT TOTAL KNEE SURGERY, GALL BLADDER REMOVAL, 11 SPINAL SURGERIES, RECTAL BLEEDING, ILEOSTOMY, NEPHROSTOMY TUBE, HERNIA REPAIR WITH MESH, UROSTOMY REVERSED, OLIF AND PLIF ON L1&2, DVT, CLOTTING DISORDER, LOWER GI BLEED, MICROCYTIC ANEMIA, SEIZURES. ALLERGIES: ATORVASTATIN, BACTRIN, METOCLOPRAMIDE, MIDAZOLAM, CAPSAICIN, CODEINE, COLESTIPOL, DULOXETINE, LOVASTATIN, PRAVASTATIN, SIMVASTATIN, ROSUVASTATIN. NEVER A SMOKER AND NEVER USED SMOKELESS TOBACCO. NO ALCOHOL OR DRUG USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600756 SYNCHROMED III PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8667-20 00763000597023

    Patients

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