Information was received from a manufacturing representative (rep) regarding a trial patient.The rep reported that the patient had one lead implanted during their trial on (b)(6) 2017, and during the lead insertion, the patient was having lightheadedness, dizziness, and feeling warmth.It was noted that the physician gave the patient medication to prevent pain.The rep stated that the patient had called them, and left them a voicemail indicating that they had fainted at home on (b)(6) 2017.The rep called and spoke to the physician on (b)(6) 2017, and it was noted that the patient was advised to turn their stimulation off for the day.It was mentioned that the patient went to the emergency room on (b)(6) 2017, and the physician explanted the lead.The rep has not heard anything further from the patient.No further complications were reported.Indication for use is unknown.It was noted that the patient has a pre-existing history of fainting, lightheadedness, and dizziness with any type of pain, including epidural injections.
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Additional information received from the manufacturing representative (rep) indicated that the patient¿s lead was discarded in the trash after the physician pulled them.They stated that they were not notified that the patient was going to have their leads pulled.The rep noted that the patient stated their leg pain was taken away when the stimulation was on.However, since the trial was so short, the physician does not recommend an implant and does not want to re-trial due to the patient being at high risk.The last the rep heard from the physician was that the patient was feeling a little better.No further complications were reported or anticipated.
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