MAUDE Adverse Event Report: MEDTRONIC MEXICO UNKNOWN EXTERNAL DRAINAGE AND MONITORING SYSTEM; DEVICE, MONITORING, INTRACRANIAL PRESSURE

Model Number UNKNOWN-E

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Intracranial Hemorrhage (1891)

Event Date 02/25/2022

Event Type  Injury  

Manufacturer Narrative

B3.Please note that this date is based off the date of publication of the article as the actual event date was not provided.A2.Please note that this age is the average age of the patients reported in the article, as the actual age of patients involved was not provided.A3.Please note that this is the gender of the majority of patients reported in the article as the actual genders of patients involved was not provided.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.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.

Event Description

Radwan takroni, nirmeen zagzoog, nimita patel, amanda martyniuk, sheila singh, forough farrokhyar, arunachala trivedi, mazen alotaibi, almunder algird.Comparison of two drainage systems on chronic subdural hematoma recurrence.J neurol surg a cent eur neurosurg 84 (2023).Doi : 10.1055/a-1698-6212.Issn 2193-6315 abstract background: chronic subdural hematoma (csdh) is a common type of intracranial hemorrhage, especially among the elderly, with a recurrence rate as high as 33%.Little is known about the best type of drainage system and its relationship with recurrence.In this study, we compare the use of two drainage systems on the recurrence rate of csdh.Methods: we retrospectively analyzed the charts of 172 csdh patients treated with bedside twist drill craniostomy (tdc) and subdural drain insertion.Patients were divided into two groups: group a (n¼123) received a pediatric size nasogastric tube [ngt]), whereas group b (n¼49) had a drain commonly used for external ventricular drainage (evd).Various demographic and radiologic data were collected.Our main outcome was recurrence, defined as symptomatic re-accumulation of hematoma on the previously operated side within 3 months.Results: in all, 212 cases of csdh were treated in 172 patients.The majority of patients were male (78%) and had a history of previous head trauma (73%).Seventeen cases had recurrence, 11 in group a and 6 in group b.The use of antiplatelet and anticoagulation agents was associated with recurrence (p¼0.038 and 0.05, respectively).There was no difference between both groups in terms of recurrence (odds ratio [or]¼1.42; 95% confidence interval [ci]: 0.49¿4.08; p¼0.573).Conclusion: csdh is a common disease with a high rate of recurrence.Although using a drain postoperatively has shown to reduce the incidence of recurrence, little is known about the best type of drain to use.Our analysis showed no difference in the recurrence rate between using the pediatric size ngt and the evd catheter post-tdc.Reported events: - 6 patients presented with a recurrence of csdh.3 patients underwent further treatment to achieve satisfactory evacuation, 2 burr holes and 1 other.See attached literature article.

• Brand Name: UNKNOWN EXTERNAL DRAINAGE AND MONITORING SYSTEM
• 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: 18587894
• MDR Text Key: 333897097
• Report Number: 9612164-2024-00454
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN-E
• Device Catalogue Number: UNKNOWN-E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2024
• 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 Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male