www.fdanews.com/articles/168182-mdr-reporting-behind-483-to-medtronic-ireland
MDR Reporting Behind 483 to Medtronic Ireland
October 31, 2014
Medtronic Ireland failed to submit MDR reports within 30 days of becoming aware of an event, including two that involved the death of a patient, according to a May 15 Form 483, recently released.
The GMP Letter