MAUDE Adverse Event Report: MEDTRONIC PS MEDICAL, INC. DUET®; EXTERNAL CEREBROSPINAL FLUID (CSF) DIVERSION

Model Number	46914
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	12/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The external ventricular drainage (evd) was leaking and the nipple was found to be cracked.Replaced with new nipple under sterile conditions.Positive csf culture for streptococcus mitis / oralis.

• Brand Name: DUET®
• Common Device Name: EXTERNAL CEREBROSPINAL FLUID (CSF) DIVERSION
• Manufacturer (Section D): MEDTRONIC PS MEDICAL, INC.; 200 medtronic drive; lafayette CO 80026
• MDR Report Key: 19087291
• Report Number: 19087291
• Device Sequence Number: 7112641
• Product Code: PCB
• UDI-Device Identifier: 00763000624774
• UDI-Public: (01)00763000624774
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/09/2024
• Report Date (Section F): 01/09/2024

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
• Operator of Device: Health Professional
• Device Model Number: 46914
• Device Lot Number: 227007687
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/11/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/11/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 97 KG
• Date Report Sent to FDA: 01/09/2024