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

Model Number 27815

Device Problems Complete Blockage (1094); Infusion or Flow Problem (2964)

Patient Problems Pain (1994); Obstruction/Occlusion (2422)

Event Date 01/01/2014

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received regarding a patient implanted with a strata valve in 2014.It was stated that, for 3 months after implant, the device did not function at all.To the patient this suggested that it was plugged most likely with brain matter from the time of operation.An appointment was made with their physician and one week prior to meeting the pressure in the patient's head built enough that it "finally blew" and felt like a garden hose spraying in their abdomen.The physician decided it was okay at the time, and the patient noted that they feel if the device was plugged the debris has passed at this time.It was inquired if there were locations an x-ray could be done to determine if debris is in the valve.

Event Description

Additional information received reported that the only x-rays the patient could provide were from 3' or more away which were useless to view the valve.It was stated they had been living with the valve for 6 years and knew for a fact that it did not function properly most likely due to negligence of the surgeon not insuring the catheter was not free of debris before connecting the valve.The most likely cause was brain matter in the system probably in the tube between the catheter and the valve.The reason the patient believed this was simple physics once the debris was forced out of the catheter, it was nearly impossible to align the debris with the valve inlet causing variations in blockage.After studying the design of the valve, they had learned that they could lay on their left side and tap on the valve to dislodge the blockage enough to provide flow.It was a very undesirable position to be in but after s ix years of pain and suffering, they realized the operation of the right ventricle system and had discovered where it drained.Through no help of the medical system, the patient managed to dislodge the blockage in the natural drain there by eliminating their h ydrocephalus.The achieved this on february 11, 2021 and was still monitoring their success.It was noted they were still having issues with the organ responsible for draining the system but due to the nature of the blockage if there were any more particles in the system that could cause more blockage.The patient was confident they had solved the problem.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: STRATA II SHUNT ASSEMBLY, REGULAR
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine CA 92617
• MDR Report Key: 11446956
• MDR Text Key: 241575504
• Report Number: 2021898-2021-00060
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K042465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 04/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27815
• Device Catalogue Number: 27815
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1