MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV EDM LUMBAR DRAINAGE KIT; DEVICE, MONITORING, INTRACRANIAL PRESSURE

Model Number	27303
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
Medtronic received information regarding an external drainage and monitoring system.It was reported that the patient developed intr acranial infection after surgery for a lumbar epidural cyst and underwent lumbar cistern drainage under local infiltration anesthesia on (b)(6) 2026, to drain infected cerebrospinal fluid.The lumbar cistern drainage tube was properly secured and related precau tions were explained.As the patient¿s condition improved, during the ward round on (b)(6) 2026, the attending physician informed the patient and family that the lumbar cistern drainage tube would likely be removed within the next two days.On (b)(6) 2026, while the patient¿s family member was removing loose threads from the hem of the patient¿s clothing, they did not notice that the thread was entangled with the lumbar cistern drainage tube and accidentally strangulated and broke the drainage tube approximately 8 cm from the drainage outlet.The physician was immediately notified.A sterile vascular clamp was used to clamp the drainage tube near the patient end to prevent cerebrospinal fluid leakage and air from entering the spinal canal, thereby avoiding the risk of intracranial infection or pneumocephalus.According to medical advice, an urgent neurosurgery consultation was requested, and the lumbar cistern drainage tube was removed.Anti-infection treatment was continued, and the patient¿s vital signs, neurological symptoms, and puncture site were closely monitored.On (b)(6) 2026, the patient¿s vital signs were stable, the headache had significantly improved comp ared with before, and the dressing at the drainage site remained dry.

• Brand Name: EDM LUMBAR DRAINAGE KIT
• Common Device Name: DEVICE, MONITORING, INTRACRANIAL PRESSURE
• Manufacturer (Section D): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer Contact: justin ellis ; 4620 n. beach st.; fort worth, TX 76137 ; 7635265677
• MDR Report Key: 25254646
• Report Number: 9617601-2026-03349
• Device Sequence Number: 10541916
• Product Code: GWM
• UDI-Device Identifier: 00763000395988
• UDI-Public: (01)00763000395988(17)280407(10)231230485
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K802100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 27303
• Device Catalogue Number: 27303
• Device Lot Number: 231230485
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2026
• Initial Report FDA Received Date: 05/22/2026
• Date Device Manufactured: 05/07/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Sex: Female