Additional information: imdrf annex a, g, b, c, d grids.Correction: common device name and manufacturer narrative (chr and dhr statements) a review of the complaint history for sn (b)(6) was performed which did not confirm similar complaints with the same or related failure mode.A review of the device history record showed the device had a manufacture date of 12apr2007.The review was performed from the date of manufacture to the present date 10jun2021.A review of the device history record for sn (b)(6) was performed which confirmed that this device was not involved in a production failure which correlates to the customer reported issue.
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