Investigation conclusion: an analysis of this occurrence could not be performed without the returned product.After evaluation the cause of this complaint could not be determined.Review of the device history record found no abnormalities during manufacturing that would cause or contribute to the reported event.Complaints received from oct,20 through jan,21 for the same failure mode were reviewed and showed no trends warranting escalation related to this occurrence.Medtronic has made its supplier aware of this occurrence and will continue to monitor for future occurrences and trends.If information is provided in the future, a supplemental report will be issued.
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