The mdr with manufacturing number 1644487-2016-02598houses the reports of chest pain and device repositioning.The patient reported experiencing neck pain associated with stimulation.The device was then disabled.The patient's surgeon elected to perform an exploratory surgery.During a pre-operative system diagnostics test the patient had severe pain at their neck and it was decided that the exploratory surgery would open the neck incision.The surgeon opened the neck incision and found scarring and inflammation present.The surgeon then dissected the lead and discovered that the electrodes were placed on the wrong nerve.A tension lead fracture was also observed.The lead was then removed and a new lead was inserted.A significant drop in lead impedance was observed from 3944 ohms to 1208 ohms once the new lead was placed on the nerve and connected to the generator the explanting facility disposed of the explanted lead and thus no product return is expected.No other relevant information has been received to date.
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