This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that this device exhibited intermittent impedance measurements with no conclusive evidence of a malfunction or inadequate lead-to-device connection; please refer to the description for more information regarding the specific circumstances of this event.
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It was reported that this cardiac resynchronization therapy pacemaker (crt-p) and associated non-boston scientific right atrial (ra) and right ventricular (rv) leads exhibited high, out-of-range pacing impedance measurements on the rv lead, with loss of capture (loc) also observed.The ra lead was oversensing ventricular activity, resulting in inappropriate atrial tachy response (atr) episodes.It was reported both leads had triggered the lead safety switch (lss) in the past.The ra lead was left in the unipolar configuration and the rv lead was reprogrammed to bipolar and the lss was programmed off.Now, however, the rv lead was intentionally reprogrammed to unipolar to obtain in-range pacing impedance measurements and normal threshold values.The sensitivity on the ra lead was decreased to mitigate oversensing the rv activity.A new remote follow-up was planned, where data was to be reviewed to ensure these programming changes were effective.The device and competitors leads remain in service.No adverse patient effects were reported.
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