If you have a successful trial of Spinal Cord or Subcutaneous Stimulation then a permanent implantation may be recommended.
Depending on the type of device, you may be required to be awake for the initial stages to give “feedback” during stimulation testing. This is only required if it was necessary during the your trial. As with the trial this can be uncomfortable for a short period.
A permanent implant is very similar to the trial but has some additional steps.
An incision (cut) is made where the leads are to be placed. The leads are then placed and secured (anchored) under the skin to prevent it movement.
An incision is then made (normally in the buttock area) where the battery (IPG) will be placed.
The leads are “tunnelled” under the skin to the battery pocket and connected to the battery. The battery is secured (anchored) within the pocket.
The leads and battery are then tested to ensure normal function.
The wounds are closed.
The wounds can be quite painful especially in the first few days after implantation. You will generally stay 1-2 nights until you are comfortable enough to go home.
The risks and complications:
In addition to the risks of the trial stimulator implant the following extra complications and issues can occur:
- Implant infection. If an implant becomes infected then it generally needs to be removed. The most common site of infection is the battery site. In rare circumstances the infection can spread into the spine itself. The reported rate of stimulation system infection is 5%. You need to immediately report any increasing pain, redness, swelling, discharge from wounds following a stimulator implant. You will be educated about looking after your wounds before the implantation takes place. You will be given phone numbers to contact in the event of any wound problems out of clinic hours.
- Early complications. Occasionally bleeding can occur within the wound or externally. Rarely, we will need to return to the operating theatre to control the bleeding.
- Device failure. The leads and battery can fail in rare circumstances. This requires replacement of the faulty part. If the part of the system requires revision (repair) then it is possible to damage other components of the system during repair, or introduce infection. If that is the case a completely new system may need to be implanted at a later date.
- Optimisation. The device may take longer to optimise following implantation. The device often takes 10-12 weeks to optimise. During the initial 12 weeks frequent wound checks and re-programming will be arrange for you at NIPM until the system is optimised.
- Ineffective stimulation. Even following a successful trial some systems fail to deliver the improvements that were achieved during trial. Thankfully this is relatively rare, but in our experience is in the order of 10-15%. If the system fails, then it can be taken out (explanted) or safely left in place.
- Restrictions. During education with the NIPM nursing staff, various activities and certain environments that need to be avoided following implantation will be discussed with you. Extreme bending and twisting, and lifting above the head needs to be avoided for 6 weeks after the procedure. Strong magnetic and electrical fields can interfere with the device – or potentially be. MRI scans and other industrial environments with strong magnetic fields need to be avoided. Some stimulation systems need to be turned off whilst driving. There is a comprehensive list of restrictions available from NIPM.
You will routinely be followed up at NIPM at 7-10 days, 1 month, 3 months, 6 months and 12 months after your implant to ensure your wounds are healing normally, to optimise the function of the device, and to measure how effective the device is for you.
Prior to implantation, please make sure you have any other questions about your procedure answered by the NIPM team.