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

Model Number 46914

Device Problems Disconnection (1171); Fluid/Blood Leak (1250)

Patient Problems Bacterial Infection (1735); Unspecified Infection (1930)

Event Date 10/01/2023

Event Type  Injury  

Event Description

Medtronic received information regarding an external drainage and monitoring system.It was reported that there was an unintentional /inadvertent disconnection at various locations on the system per the following: catheters disconnecting from the patient line, disconnection at the transducer attachment point, disconnection at the point where the tubing went into the luer, the cerebrospinal fluid (csf) access blue link had come out, and the patient line luer lock had become disconnected from the stopcock.The system also seemed to get air in the system excessively leading to unnecessary flushing.Csf culture came back as positive.

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.

Event Description

Kevin m.Gibas, dianne auld, stephanie parente, jean horoho, leonard a.Mermel.Infections associated with medtronic duet external ventricular drains ¿ rhode island hospital, providence, rhode island, january 2023¿january 2024.Morbidity and mortality weekly report 73 (2024).Abstract external ventricular drains (evds) are medical devices that are inserted into the ventricles of the brain to drain excess fluid, manage intracranial hypertension, monitor intracranial pressure, and administer medications.Unintentional disconnections and breaks or fractures (breaks) of evds or associated drainage system components can result in cerebrospinal fluid (csf) leakage and increased risk for evd-associated infections.After replacement of integra life sciences evd systems with medtronic duet evd systems at rhode island hospital in mid-september 2023, a threefold increase was observed in the prevalence of positive csf cultures, from 2.8 per 1,000 days with an evd in place (evd days) during january¿september 2023 to 11.4 per 1,000 evd days during october 2023¿january 2024 (rate ratio [rr] = 5.7; 95% ci = 1.5¿22.0; p = 0.01) and an eightfold increase in the prevalence of infections, from 0.7 to 6.5 per 1,000 evd days (rr = 9.8; 95% ci = 1.1¿87.3; p = 0.04).An investigation by rhode island hospital infection control during december 2023¿january 2024 identified frequent reports of disconnections and breaks of the medtronic duet evd system.A search of the food and drug administration manufacturer and user facility device experience database identified 326 reports nationwide of disconnection and breaks of components of the duet evd system, including 175 during 2023.A medical product safety network report was filed.The duet evd product was ultimately recalled in january 2024, citing disconnections of the evd system and reports of csf leakage and infection.Given the widespread use of evd systems by neurosurgery centers and the risk for evd-associated infections, a strategy for future consideration by hospital infection prevention and control programs might be inclusion of evd-associated infections in hospital surveillance programs to rapidly identify increases in these events and determine factors related to such infections to prevent additional infections.Additional information received stated that csf cultures of specimens obtained from the seven patients during october 2023¿january 2024 were positive for bacterial growth; five of these cultures grew coagulase-negative staphylococci, one grew viridans group streptococci, and another grew streptococcus gordonii, streptococcus salivarius, and rothia species.See attached literature article.

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.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: DUET®
• 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: 18537546
• MDR Text Key: 333164840
• Report Number: 9612164-2024-00289
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K983799
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 46914
• Device Catalogue Number: 46914
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/04/2024
• Initial Date FDA Received: 01/18/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/31/2024
• 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): Other