It was reported that the patient is experiencing muscle spasms with vns stimulation.When the device stimulates, patient's muscle by the neck twitches.All of the diagnostics were within normal limits.Patient underwent parathyroid surgery and since then, the patient has had bulging of the muscle over the left side of his neck with vns stimulation.Since reducing the output current , the bulging was reported to be tolerable.Patient underwent lead revision surgery due to painful stimulation in the muscle.The explanted lead was received.Analysis is underway but has not been completed to date.
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A portion of the lead assembly (body) including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product.The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.No obvious anomalies were noted.The set screw marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present.Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified.Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portions of the device which may have contributed to the stated complaints.
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