Patient had a generator replacement.Explanted generator was returned.Generator analysis was performed.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.Due to the disparity between the battery voltage and battery consumption value the pulse generator was opened.A visual assessment on the pulse generator pcba showed contaminates on the trimmed edge of the pulse generator pcba.The contamination that was observed on the trimmed edge of the pcba suggested probable electrical paths (resistive path) were established between the copper edges on the trimmed edge of the pulse generator pcba, which contributed to the supply current conditions.Remaining residual material on the pulse generator pcba edge after the ¿test tab¿ removal manufacturing process resulted in increased current consumption (out of speciation) for both standby and pulsing modes of operation.Per a review of the manufacturer's device history records, the generator passed final quality and functional specifications prior to release.The generator was laser-routed.From a previous internal investigation, it is known that some laser-routed devices may be susceptible to premature battery depletion.The observed premature battery life indicator was most likely caused by conductive debris from the laser-routing process, which resulted in current leakage paths and premature depletion.No further relevant information has been received to date.
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