- We are aware of recent stories about the medical technology sector that mention SynchroMed™. We recognise the seriousness of the individual case reported and extend our sympathy to the individual and their family.
- The TGA is respected globally for its science-based approach to medical technology regulation. The TGA’s robust framework incorporates pre-market assessment, ongoing monitoring and regulatory oversight to ensure approved technologies meet appropriate standards of safety and efficacy and support timely patient access to important medical innovations.
- Patient safety is Medtronic's highest priority. Through rigorous quality processes, adverse event reporting, and post-market surveillance, we endeavour to meet all applicable TGA requirements.
Media Statements
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22 July, 2026
Statement on recent media coverage about medical technologies
Information regarding SynchroMed™
- SynchroMed™ II is an established global therapy for severe chronic pain and severe spasticity, supported by more than two decades of clinical evidence and extensive real-world use among clinicians.
- Publicly available data demonstrate that the incidence of paralysis associated with the SynchroMed™ system is extremely rare, and we believe the benefits of this technology outweigh its risks.
- The Neuromodulation Society of Australia and New Zealand (NSANZ), the peak professional body representing related clinicians and healthcare professionals, issued a statement noting that their assessment is that the neurological event claimed in the reports are not related to the patient's intrathecal therapy.
- Patients with concerns should consult their healthcare professional for advice tailored to their individual medical history and treatment plan.