MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY MEDTRONIC DUET EXTERNAL DRAINAGE AND MONITORING; EXTERNAL CEREBROSPINAL FLUID (CSF) DIVERSION

Model Number 46913

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

Event Date 11/26/2023

Event Type  malfunction  

Event Description

External drainage system became disconnected, csf (cerebrospinal fluid) sent for infection.Collection system changed out again.

• Brand Name: MEDTRONIC DUET EXTERNAL DRAINAGE AND MONITORING
• Type of Device: EXTERNAL CEREBROSPINAL FLUID (CSF) DIVERSION
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY
• MDR Report Key: 18312274
• MDR Text Key: 330428747
• Report Number: MW5149142
• Device Sequence Number: 1
• Product Code: PCB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/07/2023

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 Operator: Health Professional
• Device Model Number: 46913
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/11/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian