| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00702-1 |
| Product Name/Description |
Medtronic deep brain stimulation (DBS) devices
Models :
Activa PC 37601 (ARTG# 160118)
Activa SC 37603 (ARTG# 188034)
Activa RC 37612 (ARTG# 160117)
Kinetra 7428 (ARTG# 134476)
Soletra 7426 (ARTG# 134475) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
6/06/2016 |
| Responsible Entity |
|
| Reason/Issue |
Medtronic has become aware of a reported event of inability to swim following DBS implantation and initiation of DBS therapy for Parkinson’s disease in a patient who was an experienced swimmer.
Information will be added in the future to Medtronic’s Deep Brain Stimulation (DBS) labelling in relation to loss of co-ordination, including the inability to swim. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
Medtronic is advising surgeons and patients to be aware that loss of coordination may be a side effect of DBS therapy, and may result in, for example, the inability to swim. Patients should be made aware that participating in any activities requiring coordination that they were previously able to perform may place them in an unsafe situation; therefore these activities should be performed under supervision after DBS therapy is first turned on and after programming changes until any effects of their DBS therapy on coordination are understood. Medtronic is also updating the product labelling to include information in relation to the loss of coordination. For more information, please see https://www.tga.gov.au/alert/medtronic-deep-brain-stimulation-devices-multiple-models. This action has been closed-out on 16/02/2017. |
| Contact Information |
02 9857 9000 - Medtronic |