| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00202-1 |
| Product Name/Description |
Medtronic Reveal LINQ Insertable Cardiac Monitor (ICM)
Model Number: LNQ11
ARTG Number: 218791 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
26/02/2016 |
| Responsible Entity |
|
| Reason/Issue |
Medtronic has identified that due to the sensitivity of an algorithm used in the Reveal LINQ ICM, the Recommended Replacement Time (RRT) alert may be prematurely triggered in some devices.
The RRT alert is an indicator for when the Reveal LINQ device should be replaced, therefore the premature alarm indicates replacement before it is necessary. This matter does not impact the ability for the Reveal LINQ device to safely continue collecting data. Manual data transmissions may also still continue. Device battery capacity is not affected.
Medtronic has not received any reports of patient complications or injury related to this issue.
Medtronic has observed an occurrence rate of 0.45% of devices experiencing this issue.
|
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
Medtronic is advising clinicians that prophylactic device replacement is not recommended unless the clinician determines the loss of daily wireless transmissions outweighs the potential complications associated with device replacement. If a premature RRT alert is confirmed and EOS status is displayed, options to continue ongoing monitoring include remote manual transmissions or performing an interrogation of the programmer. Medtronic will be providing a software update as a permanent correction. For more information, please see https://www.tga.gov.au/alert/medtronic-reveal-linq-insertable-cardiac-monitor.
Thia action has been closed out on 08 Jun 2017 |
| Contact Information |
02 9857 9053 - Medtronic |