Complications and Risks
- Abnormal wound healing: Skin infection around the implants sites is seen in about 3.5% of patients. Theoretically this infection may spread to the membranes lining the brain and the brain itself. Prevention of such an infection requires that implanted leads, patient cable and pulse generator be removed for a period of four to six weeks.
- Cerebral bleeding: When implanting the electrodes, very small vessels in the brain, not previously evident in the MRI planning images, may be injured. If this should result in a large bleed causing paralysis or speech disturbance or a life-threatening condition, a further operation will be required to remove the bleed, the consequences of which may, in individual cases, not be foreseeable. In our department the risk of bleeding complications after lead implantation is 0.6%, and in the reported literature up to 1.3%. So far, we have not lost a single patient to bleeding complications.
- CSF fistula (Cerebrospinal fluid (= CSF) seeping from the skin incision) and cerebral edema (brain swelling) are extremely rare complications, which we have not seen in our own patients and only come across in the literature.
- Seroma: Accumulation of fluid around the pulse generator (<1%). While in most cases the fluid can be drained through a needle, at times it may become necessary to remove the pulse generator for a period of three to four weeks.
- Bleeding during patient cable implantation: This cable is tunneled under the skin with a special instrument. If this step of the procedure is complicated by major bleeding, the operation may have to be broadened to stop the bleeding (risk 0.3%).
- Hardware related complications
- Lead migration/malpositioning (4 - 5%)
- Lead fracture (5%)
- Skin lesion (erosion) above the implanted material (~ 1%)
- Cosmetic aspects: After implantation the pulse generator is markedly noticeable under the skin as a protrusion. In quite slender patients the string-like patient cable may also become noticeable under the skin. In rare cases (<1%), a somewhat stiff scar may develop where the patient cable passes over clavicle, possibly resulting in a pulling sensation when turning the head.