(b)(4).Post marketing vigilance concurrently with engineering led an evaluation of one device opened by the account.This evaluation was based on a technical review of all data received from the site, a pmv review of manufacturing records, pmv review of complaint trends, an engineering evaluation and an evaluation of the returned device.A pmv needle was loaded onto the subject instrument.The needle was found to function properly when applied through layers of test media.Pressure was exerted on the needle in all directions and from both sides of the jaw to simulate clinical conditions.The needle was loaded and unloaded without difficulty.No difficulty was experienced in loading, unloading, or toggling the needle.Engineering confirmed the device met specifications.Visual and functional testing of the returned sample confirmed the product met quality release specifications that were tested regarding the reported conditions.A review of the device history record indicates this lot number was released meeting all medtronic quality release specifications at the time of manufacture.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.
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