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 Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received information regarding an external drainage and monitoring system.It was reported that the patient had a left cer ebellar meningioma discovered six months ago and underwent gamma knife treatment for more than five months.Seeking further surgical cure, the patient visited our outpatient clinic and was admitted to the neurosurgery department with a diagnosis of left cerebellar meningioma.After admission, routine blood, urine, and stool tests, liver and kidney function tests, blood glucose, coagulation function, crossmatch, ecg, chest and abdominal ct, cardiac ultrasound, and enhanced cranial mri were performed to clarify the diagnosis.Surgery was scheduled, and on (b)(6) 2026, under general anesthesia with endotracheal intubation, the patient underwent left re trosigmoid craniotomy for microsurgical removal of the left cerebellar hemisphere meningioma, cerebrospinal fluid leak repair, decompressive craniectomy, epidural drainage, and lumbar pond drainage.On (b)(6) 2026, a lumbar pond drainage device was used to place a lumbar pond catheter for cerebrospinal fluid drainage.During placement, the doctor found that the built-in three-way valve of the drainage device was defective, but pale-yellow cerebrospinal fluid was still drained.The volume could not be accurately controlled, resulting in prolonged surgery time, increased risk of infection, and the possibility that excessive drainage could endanger the patient¿s life at any time.Upon discovering the problem, use was immediately stopped, and the following measures were taken: the lumbar pond drainage device was immediately replaced, and a new lumbar pond catheter was inserted for drainage.; according to medical advice, the patient received an intravenous infusion of 100 ml 0.9% sodium chloride injection plus 1 g cefazolin sodium for injection to prevent infection.The patient¿s intraoperative vital signs and condition were closely monitored; the situation was immediately reported to the medical equipment department, which informed the supplier to investigate.The adverse event improved on (b)(6) 2026.
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.

• 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: 24638206
• Report Number: 9617601-2026-01893
• Device Sequence Number: 13222217
• Product Code: GWM
• UDI-Device Identifier: 00763000395988
• UDI-Public: (01)00763000395988(17)280310(10)230695461
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/19/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 27303
• Device Catalogue Number: 27303
• Device Lot Number: 230695461
• 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: 03/19/2026
• Initial Report FDA Received Date: 03/19/2026
• Date Device Manufactured: 04/10/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female