MAUDE Adverse Event Report: MEDTRONIC VALVE DELTA 0.5; VP SHUNT

Model Number 24048

Device Problems Partial Blockage (1065); Flushing Problem (1252); Occlusion Within Device (1423)

Patient Problems Headache (1880); Failure of Implant (1924); Weakness (2145)

Event Type  Injury  

Event Description

Shunt failure.Md disconnected the proximal ventricular catheter from the valve and noted no flow from the proximal catheter.Md then attached a manometer to the proximal portion of the valve, and confirmed adequate distal runoff through the valve.This strongly suggested a proximal shunt failure.

• Brand Name: VALVE DELTA 0.5
• Type of Device: VP SHUNT
• Manufacturer (Section D): MEDTRONIC; columbia heights MN
• MDR Report Key: 8771502
• MDR Text Key: 150557564
• Report Number: 8771502
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 24048
• 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: 06/28/2019
• Distributor Facility Aware Date: 06/27/2019
• Device Age: 3 YR
• Event Location: Home
• Date Report to Manufacturer: 06/28/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Weight: 49