Table 3. Adverse Events That Occurred Within 3 Months of Spinal Cord Stimulator Implantation^a.

	No. (%)
Any adverse eventb	9 (18)
Unintentional durotomy during lead placement	3 (6)
Revision of leads	2 (4)
Deep surgical site infection requiring removal of the implanted system	1 (2)
Superficial surgical site infection treated with antibiotics	1 (2)
Pulse generator replacement	1 (2)
Micturition problems	1 (2)

^a Patients self-reported events at 3 months using fixed categories. Surgeons reported intra- and perioperative events using fixed categories. Surgical revisions were registered until trial closure. In total, 3 patients withdrew consent before 3 months, including 1 patient with a deep surgical site infection that required removal of the implanted system.

^b No patient had more than 1 adverse event. There were no recorded events of postoperative hematoma, pneumonia, thromboembolism, cardiovascular complication, anaphylactic reaction, or urinary tract infection.