The pt was reportedly implanted with a boston scientific advantage fit and a biodesign 4-layer tissue graft on (b)(6) 2011, by dr (b)(6), at (b)(6) hospital in (b)(6).The pt and her attorney have alleged that as a result of these products being implanted in the pt, the pt has experienced pain, injury, and has undergone medical treatment.The following information was not provided by the complaint: specific information of the alleged injury.Specific information regarding whether intervention was performed.Specific information regarding why intervention was performed or what type / to what extent intervention was performed.Specific correlation between device performance and alleged injury.Current pt status.
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Product expire date unknown; lot number not provided.Product catalog number, product unspecified.Product manufacture date unknown; lot number unknown.Ec method/results - as product not returned to cbi.Conclusions - root cause inconclusive due to lack of details provided by the complainant.Investigation into this claim included a review of the claim allegations and all other communication and investigation into this report/claim is being handled by our attorney.Based on the information provided by the complainant, details regarding a specific correlation between the biodesign 4-layer tissue graft's performance and the alleged injury remain unknown.A root cause of the claim allegations is inconclusive due to lack of details provided by the complaint.All other matters relating to this litigation are being handled by our attorney.If/when additional information is obtained, a follow-up mdr will be filed.
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