GM4 ATCO.MED.B.010
Cardiovascular system
ED Decision 2015/010/R
PACEMAKER
(a) Scintigraphy may be helpful in the presence of conduction disturbance/paced complexes in the resting ECG.
(b) Experience has shown that any failures of pacemakers are most likely to occur in the first three months after being fitted. Therefore, a fit assessment should not be considered before this period has elapsed.
(c) It is known that certain operational equipment may interfere with the performance of the pacemaker. The type of pacemaker used, therefore, should have been tested to ensure it does not suffer from interference in the operational environment. Supporting data and a performance statement to this effect should be available from the supplier.
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