St. Jude Medical Tendril MRI LPA1200M, Руководство пользователя

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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)
Pacemaker mediated tachycardia (PMT) 20 2.17% 21 0.014
Pain at device site 1 0.11% 1 0.001
Pectoral stimulation 1 0.11% 1 0.001
Pericardial effusion 4 0.43% 4 0.003
Pericarditis 3 0.33% 3 0.002
Phrenic nerve/diaphragmatic stimulation 1 0.11% 1 0.001
Pleural effusion 1 0.11% 1 0.001
Pneumothorax 7 0.76% 7 0.005
Pocket site/incision pain lasting greater than 72
hours post implant
5 0.54% 5 0.003
Repetitive Nonreentrant Ventriculoatrial
Synchrony
1 0.11% 2 0.001
Set screw damage 1 0.11% 1 0.001
Tachycardia 1 0.11% 1 0.001
Thrombo-embolic event 9 0.98% 9 0.006
Undersensing - RA Lead 2 0.22% 2 0.001
Undersensing - RV Lead 2 0.22% 2 0.001
Undersensing - PG 1 0.11% 1 0.001
Table 2. MRI study events not adjudicated as either observations or complications
ORE Description # of Patients 2 # of Events Comments
Acute Encephalopathy 1 1 Hospitalized for general weakness, altered
mental status and mild CHF.
Angina 6 7 Patients hospitalized for chest pain;
angioplasty performed in one patient,
angioplasty and stenting performed in one
patient and stent placed in one patient. No
action taken in one patient.
Aortic Valve
Replacement 1 1 Patient had history of aortic stenosis; valve
replaced with no sequelae.
Arrest –
Cardiopulmonary
1 1
Patient brought to ER in full arrest;
cardioverted and intubated. Patient
ultimately expired.
2 Some patients experienced more than one event and therefore the number of patients is less than the number of events.