MAUDE Adverse Event Report: MEDTRONIC STRATA 2 ADJUSTABLE VALVE; SHUNT, CENTRAL NERVOUS SYSTEM

Catalog Number 42866

Device Problems Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

Patient Problem Loss of consciousness (2418)

Event Date 09/18/2017

Event Type  Injury  

Event Description

The patient was admitted on (b)(6) 2017 diagnosed with hydrocephalus and went to surgery for ventriculoperitoneal shunt failure.Valve was replaced due to proteinaceous material in it.On (b)(6) 2017, pt became unresponsive and was taken to surgery.The valve was detached and tested and determined by the surgeon it was malfunctioning even though it was relatively new.A new strata adjustable valve was attached to the catheter.

• Brand Name: STRATA 2 ADJUSTABLE VALVE
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 6922102
• MDR Text Key: 88913698
• Report Number: MW5072633
• Device Sequence Number: 2
• Product Code: JXG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/04/2017
• 2 Devices were Involved in the Event: 1 2

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 Catalogue Number: 42866
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/06/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR
• Patient Weight: 100