According to the information received from the field the recipient underwent a revision surgery due to pain over the implant site.Reportedly the pain was caused by the skin being to tight above the implant.During this surgery in (b)(6) 2018 the electrode array was inadvertently pulled out of cochlea, which was confirmed by diagnostic imaging.Thus, the concerned device was explanted and the recipient was re-implanted.The device is not available for investigation.This is combined initial and final report.
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In (b)(6) 2018 a repositioning surgery was performed because of complaints of pain around the area of the implant.According to the surgeon, the skin was too tight over the implant, causing the pain.In the original surgery, no implant bed was drilled.The patient had been a non-user for some time.After the surgery in situ measurements showed changes; the speech understanding scores were low.However, they were always low, even before repositioning surgery.Hence it was concluded that during the repositioning surgery the electrode array got inadvertently pulled out of the cochlea.The user was reimplanted a new device on (b)(6) 2019.
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