It was reported that during a routine replacement procedure, the header of this device was found to be damaged.A piece from the related accessory was observed to be broken off of the port plug.It was also noted that prior to insertion of the torque wrench, one of the set screws seal plugs was found to be slightly protruding from the header of the device.The replacement procedure was successfully completed by implanting of a new device.No adverse patient effects were reported.This device is expected for return.
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