| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00673-1 |
| Product Name/Description |
Medtronic Activa PC, Activa SC, Activa RC, Kinetra and Soletra Implantable Deep Brain Stimulators (DBS)
Activa PC
Model Number: 37601
ARTG Number: 160118
Activa SC
Model Number: 37603 and 37602
ARTG Number: 188034
Activa RC
Model Number: 37612
ARTG Number: 160117
Kinetra
Model Number: 7428
ARTG Number: 134476
Soletra
Model Number: 7426
ARTG Number: 134475 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
21/07/2015 |
| Responsible Entity |
|
| Reason/Issue |
Medtronic’s monitoring of reported events, clinical trials and published literature has resulted in labelling updates:
Warnings:
- Severe, life-threatening dystonia symptoms, including status dystonicus, during ongoing or loss of therapy may result in respiratory compromise and rhabdomyolysis. Rarely, rhabdomyolysis may progress to multi-organ failure & death.
- Cessation or reduction of stimulation may lead to an increase in seizure frequency or severity of epilepsy. Symptoms may return with an intensity greater than was experienced prior to system implant, including the potential for status epilepticus.
Adverse events:
- Meningitis, encephalitis or brain abscess resulting from infection
- Focal oedema to the area around the lead
- Immediate or delayed intracranial haemorrhage or cerebral infarction which could be symptomatic, or which could result in temporary or permanent neurological injury or death
- Aseptic intraparenchymal cyst formation around the lead tip. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
The labelling updates further clarify potential risks which have been reported with DBS Therapy. Medtronic is providing the information about the labelling updates to help physicians who are implanting and managing patients to give them visibility into the upcoming changes for labelling and help them with management of their current patients treated with DBS Therapy.
Regarding DBS Therapy for Dystonia, physicians are advised to monitor patients receiving DBS Therapy for the above symptoms and emphasise the importance of contacting the physicians if patients experience worsening of seizure frequency or severity.
Regarding DBS Therapy for epilepsy, it is important that the patient or caregiver knows how to use the patient programmer in case the neurostimulator is accidentally turned off . This action has been closed-out on 15/08/2016. |
| Contact Information |
1800 668 670 - Medtronic |