MAUDE Adverse Event Report: MEDTRONIC LUMBAR DRAIN CATHETER CLOSED TIP; VENTRICULOSTOMY

Model Number 46419

Device Problem Material Integrity Problem (2978)

Patient Problem No Information (3190)

Event Date 12/14/2015

Event Type  malfunction  

Event Description

Catheter tip sheared during lumbar drain procedure, retained, new catheter placed with good csf flow.

• Brand Name: LUMBAR DRAIN CATHETER CLOSED TIP
• Type of Device: VENTRICULOSTOMY
• Manufacturer (Section D): MEDTRONIC; minneapolis MN 55432
• MDR Report Key: 5334194
• MDR Text Key: 34760277
• Report Number: MW5058788
• Device Sequence Number: 1
• Product Code: LKG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 46419
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 80 YR