Lsi received medwatch form # mw5075034 from cdrh on (b)(6) 2018.On (b)(6) 2018, lsi reached out to cdrh via email in an attempt to obtain information regarding the user facilty contact information associated with the event.Cdrh infomred lsi that the original report contained all of the releasable information available and that they would not be providing any additional information.Without any additional information regarding the user facitliy or obtaining the device in question, lsi is unable to investigate this event any further.The event will be captured in the lsi complaint system as complaint number (b)(4), for trending purposes.No other actions will be taken in regard to this event.If additional information is received or if the device is returned, lsi will reopen and further investigate the event.
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