Date of event estimated.Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.
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It was reported that the patient did not adhere to no bending, lifting, twisting requirements following surgery.As a result, the patient's leads had migrated, which was confirmed via imaging.The patient also lost therapy.Surgical intervention took place where the leads were explanted and replaced to address the issue.Effective stimulation was restored.
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