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	10/16/2024
Type of Reportable Event	Serious Injury
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 had an intracranial aneurysm and was scheduled to undergo a craniotomy.A lumbar drainage tube was placed to relieve intracranial pressure and facilitate the surgery.After the surgery, bloody cerebrospinal fluid was deployed, alleviated the patient's symptoms.Lying on left side, with the back perpendicular to the bed, bent the neck and hugged the knees.Selected the 4-5 lumbar intervertebral space as the puncture point and marked it.Used the lumbar external drainage and monitoring system, routinely disinfected the skin, wore sterile gloves, and spread a sterile hole towel.Fixed the puncture skin with left hand, held the puncture needle with right hand, perpendicular to the back, and inserted the needle tip slightly obliquely toward the head along the puncture point.After the resistance suddenly disappeared and there was a sense of emptiness, slowly withdrew the needle core, and light red bloody cerebrospinal fluid could be seen flowing out.Inserted the drainage tube, connected the drainage tube to the sterile drainage bag, and after local disinfec tion, covered the puncture point with sterile gauze and fixed it with tape; then fixed the drainage tube with tape from the back to the head end.However, the drainage tube broke when it was pulled.A surgery was performed to remove the broken end of the drainage tube.
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.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: 20795769
• Report Number: 9617601-2024-00341
• Device Sequence Number: 18116496
• Product Code: GWM
• UDI-Device Identifier: 00763000343200
• UDI-Public: 00763000343200
• 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,Followup
• Report Date (Section B): 12/10/2024

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 Expiration Date: 10/30/2024
• Device Model Number: 27303
• Device Catalogue Number: 27303
• Device Lot Number: 223401473
• 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: 11/27/2024
• Supplement Date Received by Manufacturer: 12/09/2024
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 12/10/2024
• Date Device Manufactured: 11/30/2021
• 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: 62 YR
• Patient Sex: Female
• Patient Weight: 75 KG