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Author Topic: Urethra  (Read 525 times)
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dennis100
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« on: May 16, 2018, 01:40:18 AM »

Model Number 102
Event Date 04/01/2014
Event Type  Malfunction   
Event Description
Clinic notes were received indicating that the vns patient experienced an increase in seizures while she was hospitalized in (b)(6) 2014. The reason for hospitalization is unknown. It was noted that the patient had undergone a urethral procedure. An end of service condition was observed during an office visit on (b)(6) 2014. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2012. Attempts for additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
Review of the available programming and diagnostic history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4130116
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