MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY STRATA II; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Loss of Vision (2139); Cognitive Changes (2551)

Event Date 10/01/2020

Event Type  Injury  

Event Description

Had blindness, cognitive issues.Shunt setting changed with no known cause.Fda safety report id# (b)(4).

• Brand Name: STRATA II
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY
• MDR Report Key: 11692968
• MDR Text Key: 246464416
• Report Number: MW5100846
• Device Sequence Number: 1
• Product Code: JXG
• 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: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 36 YR
• Patient Weight: 118