Infections Associated with Medtronic Duet External Ventricular Drains — Rhode Island Hospital, Providence, Rhode Island, January 2023–January 2024

Investigation and Results

During January–September 2023, over 1,498 days with an EVD in place (EVD days), four patients with EVDs, including one with a confirmed infection, had positive CSF cultures^† (2.8 positive cultures and 0.7 infections per 1,000 EVD days) (Table). During October 1, 2023–January 10, 2024, over 614 EVD days, seven patients had positive CSF cultures, including four with confirmed EVD infections (11.4 positive cultures and 6.5 infections per 1,000 EVD days), representing an approximate threefold increase in positive CSF cultures (rate ratio [RR] = 5.7; 95% CI = 1.5–22.0; p = 0.01) and an eightfold increase in the prevalence of infections (RR = 9.8; 95% CI = 1.1– 87.3; p = 0.04) after transition to the Medtronic Duet EVD system^§ (7,8).

CSF cultures of specimens obtained from 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. Six of these seven patients had received Medtronic Duet EVD systems, and one had received an Integra Life Sciences EVD system. The patient who received the Integra Life Sciences EVD had their EVD placed in the operating room; all patients who received the Medtronic EVDs had them placed in either the emergency department or NCCU.

As part of the investigation, information was collected about the providers who cared for the patient (including their level of training) and hospital locations occupied by affected patients or where they were provided care. Specimen collection procedures, infection control practices, and the data from the hospital’s adverse events reporting system (SafetyNet) were also reviewed.

Investigation of Staff Members and Hospital Locations

No common health care providers (including surgeons, house officers, nursing staff members, and staff members who inserted the EVDs or collected EVD cultures) or geographic locations or units were shared by all seven patients. Further, no recent changes were identified in procedures for collecting or processing CSF specimens or in Rhode Island Hospital’s EVD infection prevention program.

Interviews with neurosurgeons and NCCU staff members revealed reports of frequent unintentional disconnections and breaks of the Medtronic Duet EVDs tubing, which had not been observed with the Integra Life Sciences EVD system that was previously used at Rhode Island Hospital. Staff members reported that these events consisted of the collecting tubing disconnecting from the patient-line stopcock connectors (Figure). When this issue was identified, nursing staff members, neurosurgeons, and NCCU providers were notified to report these events in SafetyNet, the Rhode Island Hospital adverse event reporting system, to track these occurrences. No issues with staff member training related to the device, improper use of the device by staff members, or any other staff-related issues were identified.

Review of SafetyNet Data

Review of the Rhode Island Hospital SafetyNet data found no reports of improper use of the Medtronic EVD system and no reports of adverse events related to EVD systems before the switch to the Medtronic Duet EVD system in September 2023; however, after transitioning to the Medtronic EVD system, nine EVD-related adverse events were reported in SafetyNet, all related to disconnections or breaks of Medtronic Duet EVDs. A search of the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database using the search term “Medtronic Duet” identified 326 medical device reports involving malfunction of the Medtronic Duet EVD system, including 175 (54%) reports during 2023, 120 (69%) of which were for disconnection of components of the EVD system, and 23 (13%) of which were breaks in the EVD system^¶ (9).