MAUDE Adverse Event Report: MEDTRONIC MEXICO EXACTA DRAINAGE SYSTEM, 100ML; DEVICE, MONITORING, INTRACRANIAL PRESSURE

Model Number	46705
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2024
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 on (b)(6) 2024, the patient had a subdural effusion and underwent external drainage surgery.During the operation, the three-way valve joint was tested and found to be cracked and leaking.The device was replaced with a new one.There was a procedure delay of 30 minutes.The patient's status at the time of the report was alive-with injury as the patient came to the hospital for treatment due to sudden dizziness, headache, nausea and vomiting for 2 days.Emergency head ct showed: left occipital lobe hemorrhage.Physical examination upon admission: the patient was confused and in very poor spirits.The pupils on both sides were equal in size and round, with the left to right = 4:4 mm.The patient had a slow light reflex, irrelevant questions and answers, was irritable, did not cooperate with the physical examination, was in a passive position, and was pushed into the ward on a cart.The right limb muscle strength was level 2, the left limb muscle strength was level 4, the left pathological signs were positive, and the right was negative.

• Brand Name: EXACTA DRAINAGE SYSTEM, 100ML
• Common Device Name: DEVICE, MONITORING, INTRACRANIAL PRESSURE
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 19614443
• Report Number: 9612164-2024-03005
• Device Sequence Number: 15001957
• Product Code: GWM
• UDI-Device Identifier: 00763000333706
• UDI-Public: 00763000333706
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K201118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/26/2024

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: 46705
• Device Catalogue Number: 46705
• Device Lot Number: 227307881
• 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: 06/18/2024
• Initial Report FDA Received Date: 06/26/2024
• Date Device Manufactured: 09/06/2023
• 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: 38 YR
• Patient Sex: Female
• Patient Weight: 58 KG