Consumers and health professionals are advised that Medtronic Australasia, in consultation with the TGA, has issued a hazard alert for Medtronic StrataMR Adjustable Valves and Shunts due to the potential for under-drainage of cerebrospinal fluid.
Medtronic is also undertaking a recall of devices that have not yet been implanted.
Medtronic StrataMR Adjustable Valves and Shunts are used in the management of hydrocephalus. They control the flow of cerebrospinal fluid being drained from the brain to relieve pressure.
The issue can arise when tools being used to operate an adjustment mechanism are misaligned and the wrong settings are applied to the device.
Worldwide, Medtronic experienced an increase in the occurrence rate of StrataMR reports in January 2017 relating to incorrect flow or fluid level change. Following this increase, the complaint rate reached 1.45% of total units distributed since November 2015. Of all units distributed, 1.1% have required revision surgeries.
There have been no reports of deaths related to this issue.
If this issue occurs the expected adverse health consequences are the same as those experienced during the course of hydrocephalus management (for example, headaches, lethargy, nausea, vomiting), or those related to follow-up surgery.
If left untreated, under-drainage has the potential to lead to serious consequences such as coma and death.
Information for consumers
If you or someone you provide care for been implanted with an affected Medtronic StrataMR Adjustable Valve and Shunt, you should be contacted by your neurosurgeon regarding this issue.
If you have any questions or concerns about this issue, contact your neurosurgeon.
Information for health professionals
If you are treating someone who has received an affected Medtronic StrataMR Adjustable Valve and Shunt, be aware of this issue.
Patients with any implants such as this should be followed up by their neurosurgeon if they have any questions or concerns.
Information for neurosurgeons
Medtronic has written to neurosurgeons who have implanted affected devices providing detailed information about this issue.
Neurosurgeons are advised to stop implanting the device.
A full list of affected products is listed in the ‘Additional information’ section below.
Additional information
The affected products (ARTG numbers 129681 and 134740) are:
- StrataMR valve, small
- E06139
- E06476
- E09475
- E12753
- E13484
- E13641
- E18556
- E18557
- E18558
- StrataMR valve, regular
- E06016
- E06138
- E06412
- E09619
- E12266
- E12952
- E18559
- E18560
- 46955
- StrataMR shunt assembly, small
- E12932
Reporting problems
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA’s monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.