MAUDE Adverse Event Report: MEDTRONIC MEXICO EXACTA¿; DEVICE, MONITORING, INTRACRANIAL PRESSURE

Model Number 46700

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/22/2024

Event Type  malfunction  

Event Description

Medtronic received information regarding an external drainage and monitoring system.It was reported that during the normal post-operative drainage process, leakage was found from the proximal three-way near the tip side.The system was replaced with a new one to complete the drainage treatment.The patient's status at the time of the report was alive-no injury.The patient's medical history was brain tumor.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The external drainage system was returned for analysis.After visual inspection the drainage device did not meet the requirements for leak testing due to a crack in the male luer arm for the injection port on the patient line stopcock.It is unknown how or when this damage occurred.Codes: b01, c07, d02 a medical safety review was performed on the reported issue and based on the investigation results can be concluded that the cause of the complaint could not be determined.Unfortunately, the complaint did not contain any image or video, which could have been useful for further research and sample was not available for analysis.The review of the device history record found no abnormalities during manufacturing that would cause or contribute to the reported event.The review of the manufacturing process and quality indicators found no abnormalities that could have caused the defect.Claims received from june 2023 to november 2023 for the same failure mode "leakage" were reviewed and 2 claims were found and determined to be unsubstantiated.There were no adverse patient effects as result of this incidence.This investigation will be closed with the information provided.Medtronic will continue to monitor for future occurrences and trends.The device history review (dhr) was performed on the device 226727122, the manufacturing date was 07-jun-2023, and the expiration date is 05-may-2028.The product labeling retain content match the dmr requirements.The correct components and relevant consumables were utilized.All acceptance activities meet the acceptance criteria and sample size requirements.The dhr was correctly approved prior to product release.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: EXACTA¿
• Type of Device: 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: 18649977
• MDR Text Key: 334642845
• Report Number: 9612164-2024-00596
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K983799
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/11/2024

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
• Device Operator: Health Professional
• Device Model Number: 46700
• Device Catalogue Number: 46700
• Device Lot Number: 226727122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/05/2024
• Initial Date FDA Received: 02/06/2024
• Supplement Dates Manufacturer Received: 03/08/2024
• Supplement Dates FDA Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Sex: Male