The patient's generator was replaced due to reported prophylactic battery replacement.The explanted product was received by the manufacturer at end of service condition.Product analysis was completed on the returned generator and found evidence of premature battery depletion.Upon opening the generator can, visual analysis identified contaminates on the trimmed edge of the printed circuit board assembly (pcba).The post-burn electrical test indicated that the contamination on the trimmed edge of the pcba was suggestive of probable electrical paths that were established between the copper edges, which could contribute to premature battery depletion.The manufacturer's device history records were reviewed.The generator passed final quality and functional specifications prior to release.The generator was subjected to laser-routing process.
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