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3
Adverse Events
The Reported Adverse Events (page 3) summarize the adverse events in the Accent MRI ™
Pacemaker and Tendril MRI ™ Lead Investigational Device Exemption Study (MRI Study). The MRI
study was a prospective, multi-center clinical investigation designed to evaluate the safety and
efficacy of the Accent MRI pacemaker system in a patient population indicated for implant of a
pacemaker within and outside of an MRI environment.
Per the investigational plan, an adverse event was defined as any unfavorable clinical event which
impacts, or has the potential to impact the health or safety of a patient caused by or associated
with a study device or intervention.
Adverse events were classified as complications or observations based on the following definitions:
 Complications are defined as adverse events that require invasive intervention (e.g. lead
dislodgment requiring repositioning).
 Observations are defined as adverse events that can be managed without invasive
intervention (e.g., oversensing or loss of pacing capture, which is remedied by
reprogramming of the pacemaker).
 Other Reported Events are any other clinical event that is submitted by the investigator
which is not caused by or associated with the study device and/or system component(s)
and/or defined as an Adverse Event.
Reported Adverse Events
The tables below list the observations and complications reported from the MRI Study, see
Summary Of Clinical Study (page 9). A total of 168 adverse events have been reported in 139
patients, of which 68 are complications and 100 are observations. None of the adverse events
were adjudicated as related to or caused by the study MRI scans.
In addition, 103 other events were reported in 73 patients. None of these events were adjudicated
as related to or caused by the study MRI scans, the study device, or system components.
Table 1. MRI study adverse events
Event Description # of
Patients
with
AEs
1
(n=920)
% of
Patients
with AEs
#AEs AE/pt-years
(n=1,535.44
yrs)
Complications (total)
63 6.85% 68 0.044
Bleeding/Hematoma 2 0.22% 2 0.001
Cardiac Perforation 2 0.22% 2 0.001
Cardiac Tamponade 3 0.33% 3 0.002
Decompensated HF 1 0.11% 1 0.001
Device Connectivity Issue 1 0.11% 1 0.001
Device Migration 1 0.11% 1 0.001
Elevated Pacing Thresholds - RA Lead 2 0.22% 2 0.001
Elevated Pacing Thresholds - RV Lead 1 0.11% 1 0.001
Hemoptysis 1 0.11% 1 0.001
1 Some patients experienced more than one event and therefore the number of patients is less than the number of events.