Product analysis was completed on the explanted generator and leads.The generator provided expected diagnostic test results with various electrical loads and the generator performed according to functional specifications in product analysis.There were no adverse functional, mechanical or visual issues identified with the returned generator.During a visual analysis of the returned lead portion, it was noted that there was insufficient adhesive inside the connector boot, indicating the connector boot had not been properly secured.Outside of the observation regarding connector boot adhesive, the condition of the returned lead portions was consistent with conditions that typically exist following an explant procedure.The connector boot observation was captured in mfr.Report # 1644487-2019-00455 as was not likely related to the pain experienced by the patient.No further relevant information has been received to date.
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