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	10/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information regarding an external drainage and monitoring system.It was reported that on (b)(6) 2025, lumbar cistern drainage catheterization was performed under local anesthesia at the waist.After the procedure, the lumbar cistern drainage tube was securely fixed.According to medical orders, the height of the lumbar cistern drainage tube was adjusted to 10¿15 cm above the external auditory canal, and the daily drainage volume was controlled at 150¿200 ml.The patient had left upper limb muscle strength of grade 4 and was continuously restrained with a wave board and gloves.The right upper limb muscle strength was grade 1.From october 18 to 19, 2025, a total of 176 ml of light red cerebrospinal fluid was drained in 24 hours.On (b)(6) 2025, during the shift handover, it was found that the lumbar cistern drainage tube had fractured, and no cerebrospinal fluid was observed draining from the tube.The responsible physician and head nurse were immediately notified.The original product was removed.
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: 23367136
• Report Number: 9617601-2025-02178
• Device Sequence Number: 8879939
• Product Code: GWM
• UDI-Device Identifier: 00763000395988
• UDI-Public: (01)00763000395988(17)271214(10)230443355
• 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): 10/23/2025

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: 230443355
• 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: 10/23/2025
• Initial Report FDA Received Date: 10/23/2025
• Date Device Manufactured: 01/14/2025
• 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: Male