The pulse generator was received for product analysis.Visual examination noted tool marks/dents on the pulse generator case and the header had scratches on it.The marks are most likely associated with manipulation of the device during the explant procedure as the markings are consistent with devices typically used in a surgical procedure (forceps, etc.).The septum was not cored.Visible adhesive at the generator top matches up with the adhesive on the bottom of the header supporting a secure bond.The anchor tab furthest from the feed-thru capacitors is slightly bent.The anchor tab closest to the feed-thru capacitors is bent on the side furthest from the feed-thru capacitors.Visual assessment of the final manufacturing x-ray showed no abnormalities at the time of manufacture.A scanning electron microscopy (sem) was performed on the anchor welds.The sem images show appearance suggesting that a stress-induced fracture has occurred at one side of one of the anchor welds.However due to mechanical distortion (smoothed surfaces) the fracture mechanism cannot be verified.The device battery was confirmed to be depleted past end of service.The depletion was an expected event as determined battery voltage measurement and battery life calculation.The battery life calculation, based on known programmed settings, indicated 0.0 years remaining until neos = yes.The module performed according to functional specifications.Other than the header detachment, there were no performance or any other type of adverse conditions found with the pulse generator.Review of the programming history database showed no evidence of high impedance.There is no evidence of device performance being impacted while implanted.
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