(b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.Patient problem code: (b)(4).Device problem code: (b)(4).No additional information was provided by inova loudoun.Primevigilance did reach out to obtain with no success.Should additional information be available in the future, the complaint will be re-opened and investigated.All complaints are reviewed during monthly quality/safety meetings.In addition, complaints are trended at monthly quality data analyst meetings and quarterly plant management review meetings.
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