MAUDE Adverse Event Report: MEDTRONIC LP SHUNT NSC

Model Number 44421

Device Problem Difficult To Position (1467)

Patient Problems Headache (1880); Nausea (1970)

Event Date 04/08/2017

Event Type  Injury  

Event Description

Since mri, my shunt has been unable to adjust.Constant headaches/nausea.

• Brand Name: LP SHUNT NSC
• Type of Device: SHUNT
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 6705894
• MDR Text Key: 79915136
• Report Number: MW5070934
• 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: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 44421
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 54 YR
• Patient Weight: 87