CDC Report Details Medtronic Duet EVD Infection Outbreak At Rhode Island Hospital

Recalled Medtronic Duet EVD systems led to an eight-fold increase in cerebrospinal fluid infections among patients at the hospital, according to findings outlined by CDC researchers.

A new report issued by federal health officials outlines the serious infection risks with Medtronic Duet External Ventricular Drains (EVDs), which were recalled in January 2024, indicating htat the systems were linked to an eightfold increased risk of brain fluid infections at one hospital in Rhode Island.

Researchers with the U.S. Centers for Disease Control and Prevention (CDC) warn that disconnections and leaks with the recalled Medtronic Duet EVD systems caused a significant increase in cerebrospinal fluid (CSF) infections. The findings were reported on April 11 in the Morbidity and Mortality Weekly Report (MMWR).

On January 24, Medtronic issued an urgent medical device recall due to the risk of catheter disconnection from patient line stopcock connections. EVDs are used to drain the buildup of cerebrospinal fluid in the brain, monitor intracranial hypertension, monitor intracranial pressure and administer medications.

The U.S. Food and Drug Administration (FDA) gave the recall a Class I designation, due to the risk of severe injury or death to patients.

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“If a tubing disconnection occurs, potential harm to patients may include infections, cerebrospinal fluid leakage, over drainage of cerebrospinal fluid, and abnormality of the ventricles,” Medtronic wrote to customers. “Uncontrolled over drainage of cerebral spinal fluid could lead to neurological injury or death if the disconnection is undetected. The types of patient harms that have been reported in the complaints include cerebrospinal fluid (CSF) leakage and infection.”

The CDC report centers on a cluster of EVD-associated infections at a Rhode Island hospital from January 2023 to September 2023, after the hospital replaced its Integra Life Sciences EVD systems with Medtronic Duet EVD systems. The infections occurred between January and September of 2023.

According to the report, the hospital noted a threefold increase in the prevalence of positive CSF cultures, and eight times the number of CSF-related infections. The hospital indicates it received frequent reports of disconnections and breaks in the Medtronic Duet EVD system, linked to reports of leaks and infections.

“Health care institutions in the United States are required to perform surveillance for numerous infections; however, surveillance for EVD-associated infections is not mandated by U.S. regulatory agencies,” CDC researchers concluded. “Given the potential for EVD-associated infections to result in prolonged intensive care unit and hospital length of stay, increased morbidity, and increased health care costs, this is an area for further exploration by hospital infection prevention and control programs.”

Similar Medtronic Duet EVD infection outbreaks may have occurred at other facilities, but the manufacturer failed to disclose the extent of problems. However, the recall notice did claim that Medtronic was not aware of any serious neurological injuries or patients deaths related to the tubing disconnecting on EVD systems.

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