| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00155-1 |
| Product Name/Description |
Medtronic Strata II/Strata NSC Valves (including Burr Hole and Lumbar Peritoneal [LP]) used in the management of hydrocephalus
Multiple Catalogue Numbers
All Lot Numbers
ARTG Numbers: 111909, 129681, 134740, 145335, 145337, 165018, 169054, 169061 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
16/02/2017 |
| Responsible Entity |
|
| Reason/Issue |
The identified products may have a rare condition related to the Strata Valve that can lead to an inaccurate pressure level (PL) reading on the Strata Indicator Tool or StrataVarius system. The condition occurs when the magnet inside the valve becomes reverse polarised, which may occur only if a patient has been exposed to 3T MRI magnetic field or greater, and biological debris is present to an extent that the valve magnet adjustment mechanism is impacted. Medtronic's investigation identifies that a reverse-polarity magnet has a relatively small chance of occurrence (Rate: 0.007% over a two year period). Over the two year period, a total of five complaints received included three adverse events (three revision surgeries). However, only one revision surgery was confirmed to occur due to the reported product problem. There have been no reports of other instances of disease, illness, or injury. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
Clinicians are advised that the expected adverse health consequences are the same as those experienced during the course of hydrocephalus management (eg. headaches, lethargy, nausea, vomiting), or those related to a revision surgery).The IFU for the products is being updated to include the following verbiage to reinforce the warnings/precautions:
“Biological debris inside the valve may impact adjustability, and may lead to adjustment mechanism damage if exposed to 3.0 tesla MRI. If difficulty is experienced adjusting or reading the valve setting, radiographic setting confirmation should be considered. The reading from the Strata II Indicator tool or StrataVarius system may be reversed (180 degrees opposite) from the radiographic image. In this situation, radiographic imaging should be used to determine the setting of the valve.”
For further information, please refer to:
https://www.tga.gov.au/alert/medtronic-strata-ii-strata-nsc-valves .
This action has been closed-out on 20/03/2018. |
| Contact Information |
02 9857 9289 - Medtronic Product Specialist Neurosurgery |