MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV BECKER®; DEVICE, MONITORING, INTRACRANIAL PRESSURE

Model Number	26040
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Device Dislodged or Dislocated (2923); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1.Unable to provide due to the initial reported asked to remain confidential.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 external ventricular drain (evd) placed in the operating room, however, the drainage system had to be changed out for another manufacturer's device.It was stated that the drainage system was not a device that could be secured well to the iv pole like the other systems.The device hangs from the top of the pole, and the staff has to creatively secure it.The burette portion of the system being used for this particular patient became loose and was not able to be tightened to maintain the ordered level per the provider order.This created an unsafe situation for the patient, and the drainage system was disconnected and replaced by the nurse.

• Brand Name: BECKER®
• 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: 20823236
• Report Number: 9617601-2024-00365
• Device Sequence Number: 7850783
• Product Code: GWM
• UDI-Device Identifier: 00763000406066
• UDI-Public: 00763000406066
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K984053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 12/02/2024

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: 26040
• Device Catalogue Number: 26040
• Device Lot Number: 228402670
• 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: 12/02/2024
• Initial Report FDA Received Date: 12/02/2024
• Date Device Manufactured: 03/13/2024
• 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: 65 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic