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); Complete Blockage (1094); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received information regarding an external drainage and monitoring system.It was reported that to promote healing of the posterior occipital midline incision (cerebrospinal fluid leakage from the posterior midline incision after ventricular drainage tube removal), consent was obtained from the patient¿s family, and a cisternal drainage procedure was performed in the general ward.The patient was placed in the left lateral knee-flexed position.Routine disinfection and draping were performed.The l2/3 intervertebral space was selected as the puncture site.After successful local infiltration anesthesia with 2% lidocaine, the lumbar puncture needle was inserted vertically through the skin to a depth of approximately 7 cm.The stylet was removed, and clear, colorless cerebrospinal fluid flowed out.The pressure was measured at 180 mmh2o.The lumbar puncture needle was removed.The external drainage system was opened, and the puncture needle was inserted along the original puncture site and direction to a depth of approximately 7 cm.After removing the stylet, cerebrospinal fluid was observed to flow out.The cisternal drainage catheter was inserted through the puncture needle into the cistern, and it was confirmed that at least 10 cm had been placed within the cistern.The puncture needle was slowly withdrawn.Initially, clear and colorless cerebrospinal fluid flowed out, followed by bright red blood flowing out and coagulating within the tube, causing blockage.It was therefore decided to remove the drainage catheter and reinsert it.After the drainage catheter was slowly withdrawn, a fracture was observed at the cisternal end of the drainage catheter (the fracture point was approximately 11 cm from the distal cisternal tip of the drainage catheter).After reporting to the supervising physician, the puncture site was covered with sterile gauze.The patient¿s condition was closely monitored, and removal of the fractured drainage catheter segment was planned as the next step.The patient was transferred to the operating room for ¿spinal canal¿subcutaneous fractured drainage catheter removal.¿ during the operation, the fractured drainage catheter segment was completely 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.
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: 25136616
• Report Number: 9617601-2026-03031
• Device Sequence Number: 21195664
• Product Code: GWM
• UDI-Device Identifier: 00763000343200
• UDI-Public: (01)00763000343200(17)280406(10)231230483
• 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,Followup
• Report Date (Section B): 05/20/2026

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: 231230483
• 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: 05/11/2026
• Supplement Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 05/11/2026
• Supplement Report FDA Received Date: 05/20/2026
• Date Device Manufactured: 05/06/2025
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 60 KG