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

Model Number 46914

Patient Problem Insufficient Information (4580)

Event Date 01/06/2024

Event Type  malfunction  

Event Description

When checking on patient, wet area noted on pillow behind head.Evd was noted to have been disconnected at clear port proximal to the catheter in patient's head.

• Brand Name: DUET®
• Type of Device: EXTERNAL CEREBROSPINAL FLUID (CSF) DIVERSION
• Manufacturer (Section D): MEDTRONIC PS MEDICAL, INC.; 200 medtronic drive; lafayette CO 80026
• MDR Report Key: 18826021
• MDR Text Key: 336776945
• Report Number: 18826021
• Device Sequence Number: 1
• Product Code: PCB
• UDI-Device Identifier: 00763000624774
• UDI-Public: (01)00763000624774
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 46914
• Device Lot Number: 227007687
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/09/2024
• Event Location: Hospital
• Date Report to Manufacturer: 03/04/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/04/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 66 KG