Patient underwent prophylactic generator replacement due to ifi (intensified follow-up indicator)=yes.The explanted generator was received by product analysis.Product analysis for the generator was completed.An end-of-service warning message was verified in the product analysis lab and found to be associated with the output being disabled by the pulse generator, due to the pulse generator remaining ¿on¿ post explant.A visual assessment on the pcba showed contaminates on the trimmed edge of the pcba.Based on the postburn electrical test results, the contamination that was observed on the trimmed edge of the pcba suggest probable electrical paths (resistive path) were established between the copper edges on the trimmed edge of the pcba, which contributed to the supply current conditions.Remaining residual material on the pcba edge after the ¿test tab¿ removal manufacturing process resulted in increased current consumption (out of speciation) for the pulsing mode of operation, and may have been the contributing factor for the battery depletion.Design history record was reviewed for the generator.The generator passed all specifications prior to distribution.The device was laser routed.No other relevant information has been received to date,.
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