SAFETY INFORMATION

Below you will find some information on the safety profile of Medtronic DBS.


Does DBS Have a Safety Profile?

Medtronic DBS is a well established therapy and many patients have benefited from it for 30 years.

In general, 85–89% of people with Parkinson’s have improvements with DBS therapy if people are carefully selected and the neurosurgeon places the lead correctly.1

As with any major surgery, there are some risks associated with the procedure, but these are very low when DBS is performed in a specialised centres.2

For example, published studies show the following risks with Medtronic DBS systems:

  • The risk of permanent health impairments is around 1.0%, mainly caused by bleeding within the skull.2
  • As with other surgeries, death can occur. The risk of death is 0.4%.2. Although surgical procedures are different, total hip replacement, for example, has the same risk of death (0.4%) as DBS surgery.3.
  • The risk of brain haemorrhage was 0% to 5% on average, in six high quality, multicentre studies conducted in different regions.4, 5, 6, 7, 8, 9
  • The risk of infection from the device was 2.6% to 7.9% on average, in five high quality, multicentre studies conducted in different regions.2, 4, 7, 8, 9

When complications do occur in DBS, they are generally mild, short-lived and normally resolve around 30 to 90 days after surgery.7,10


RISKS

Risks of DBS therapy can include risks of surgery, side effects or device complications. Implanting the neurostimulator system carries the same risks associated with any other brain surgery.

Your doctor can provide more information about these and other potential risks and side effects. Many side effects related to stimulation can be managed by adjusting the stimulation settings. Several follow-up visits may be needed to find the best stimulation settings for you.

Risks of surgery may include:

  • Paralysis, coma and/or death
  • Bleeding inside the brain (intracranial haemorrhage)
  • Leakage of fluid surrounding the brain
  • Seizures
  • Infection
  • Allergic response to implanted materials
  • Temporary or permanent neurological complications
  • Confusion or attention problems
  • Pain at the surgery sites
  • Headache

SIDE EFFECTS

Possible side effects of brain stimulation may include:

  • Tingling sensation (paraesthesia)
  • Temporary worsening of symptoms
  • Speech problems like whispering (dysarthria) and trouble forming words (dysphasia)
  • Vision problems (double vision)
  • Dizziness or lightheadedness (disequilibrium)
  • Facial and limb muscle weakness or partial paralysis (paresis)
  • Abnormal, involuntary movements (chorea, dystonia, dyskinesia)
  • Movement problems or reduced coordination
  • Jolting or shocking sensation
  • Numbness (hypoesthesia)

Device complications

Possible device complications include:

  • Pain, lack of healing or infection where the Medtronic DBS system components are implanted
  • Infection or scarring caused by the system components eroding through your skin
  • Readjustment surgery if the lead or lead/extension connector moves, or if mechanical or electrical problems occur
  • An allergic reaction to or rejection of the system by your body
  • Tissue damage resulting from programming parameters or a malfunction of one of the parts of the system

Results may vary from patient to patient. Not everyone who receives Medtronic DBS therapy will experience the same results. Some people may experience significant symptom relief from DBS therapy, and others may experience minimal relief.

Talk to your doctor to see if Medtronic DBS therapy is right for you. For further information, please consult your healthcare professional who can explain the benefits and risks and important safety information.


References

1

Medtronic supplemental analysis: supplement to EPDA website update re patient barriers and claims-v17-Sept-2015

The 'gold standard' of evaluating the success rate of DBS is based on the overall motor function evaluation using the UPDRS III scale. The scientifically accepted method for evaluation of the MCIC (minimally clinically important change) is at least 5 points in the UPDRS III scale. The evaluation of 'off medication' allows reflection of the impact of DBS, albeit an artificially created 'off' condition. It has not been typically reported in the publications, but we have completed the above additional analyses of the databases available in both the published evidence (only randomised control trials have been considered for this). The above analysis works for Medtronic devices only.

2

Voges J, Hilker R, Botzel K, Kiening KL, Kloss M, Kupsch A. Thirty day complication rate following surgery performed for deep-brain stimulation. Mov Disord. 2007;22(10):1486-1489.

3

Blom A, Pattison G, Whitehouse S, Taylor A, Bannister G. Early death following primary total hip arthroplasty: 1727 procedures with mechanical thrombo-prophylaxis. Acta Orthop. 2006;77:347–350.

4

Okun MS, Fallo BV, Mandybur G, et al. Subthalamic deep brain stimulation with a constant current device in Parkinson’s disease: an open label randomized clinical trial. Lancet Neurology. 2012;11(12):1014-1015.

5

Schüpbach W, Rau J, Knudsen K, Volkmann J, Krack P, Timmermann L, et al. Neurostimulation for Parkinson’s disease with early motor complications. EARLYSTIM Study. N Eng J Med. 2013;368:610-622.

6

Williams A, Gill S, Jenkinson C, et al. Deep brain stimulation plus best medical therapy versus best medical therapy alone for advanced Parkinson’s disease (PD Surg trial): a randomised, open-label trial. Lancet Neurology 2010;9(6):581-91.

7

Deuschl G, Schade-Brittinger C, Krack P, et al. A randomized trial of deep-brain stimulation for Parkinson’s disease. N Engl J Med. 2006;355(9):896-908.

8

Follett KA, Weaver FM, Stern M, Hur K, Harris CL, Luo P, et al. Pallidal versus subthalamic deep-brain stimulation for Parkinson’s disease. N Engl J Med. 2010;362:2077-2091.

9

Odekerken VJ, van Laar T, Staal MJ, et al. Subthalamic nucleus versus globus pallidus bilateral stimulation for advanced Parkinson’s disease (NSTAPS study): a randomized clinical trial. Lancet Neurology. 2013;12(1):37-44.

10

Weaver FM, Follett KA, Stern M, et al. Bilateral deep brain stimulation vs. best medical therapy for patients with advanced Parkinson’s disease. JAMA. 2009;301(1):63-73.