The generator was explanted and returned due to prophylactic replacement.No allegations were made against the vns generator.During product analysis, a visual assessment on the printed circuit board assembly (pcba) showed contaminates on the trimmed edge of the pcba.The contamination that was observed on the trimmed edge of the pcba suggested probable resistive electrical paths were established between the copper edges on the trimmed edge of the pcba, which contributed to the supply current conditions.The device history record of the generator was reviewed, and it was confirmed that the device was laser-routed during the manufacturing process.The device met all specifications for release prior to distribution.Internal investigation showed that the observed premature battery life indicators were predominately caused by conductive debris from the laser-routing process resulting in leakage paths.No other relevant information has been received to date.
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