MAUDE Adverse Event Report: MEDTRONIC MEXICO BECKER®; DEVICE, MONITORING, INTRACRANIAL PRESSURE

Model Number	46129
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3.Product analysis determined that the visual inspection did not reveal any tube separations.The returned edms system had several biological debris and a drainage bag full of blood.Considering the nature of pressurized testing and safety of lab personnel, deco ntamination/testing was not permitted on the returned device.The device was discarded due presence of a big pool of blood in the product.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 tubing became dislodged between the collection chamber and collection bag.The device was originally placed on (b)(6) 2024 and in use for 6 days.The device was replaced with another manufacturer's device.The patient's status at the time of the report was alive-no injury.The patient was admitted for aneurysm subarachnoid hemorrhage (sah) with subsequent aneurysm coil placement.

• Brand Name: BECKER®
• 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: 19547635
• Report Number: 9612164-2024-02858
• Device Sequence Number: 20515935
• Product Code: GWM
• UDI-Device Identifier: 00763000333683
• UDI-Public: 00763000333683
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/17/2024

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: 46129
• Device Catalogue Number: 46129
• Device Lot Number: 227779114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2024
• Initial Report FDA Received Date: 06/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2023
• 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: 72 YR
• Patient Sex: Female
• Patient Weight: 72 KG