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

Model Number 46912

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/05/2023

Event Type  malfunction  

Event Description

Cerebrospinal fluid (csf) collection, leaking noted.Bag was changed.

• 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: 19078961
• MDR Text Key: 339815417
• Report Number: 19078961
• Device Sequence Number: 1
• Product Code: PCB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/06/2023

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 Model Number: 46912
• Device Catalogue Number: 46912
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/06/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/10/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/10/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Male