During implant surgery for the patient¿s lead, it was noticed that after the lead had been tunneled a deformity on the electrode was observed.The surgeon was able to connect the anchor and positive electrode with no issues, but when connecting the negative electrode he stated it appeared bent, and he didn¿t think it would attach to the nerve properly.There was no abnormality observed with the lead prior to the lead being removed from the packaging.It is unclear how the deformity occurred.The deformed lead was returned for product analysis which has not been completed to date.The design history record for the lead was reviewed and showed that the lead passed all quality control checks prior to being released for distribution.
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