BOSTON SCIENTIFIC CORPORATION MOMENTUM CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
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Model Number G125 |
Device Problems
Failure to Capture (1081); High impedance (1291); Connection Problem (2900)
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Patient Problem
Device Overstimulation of Tissue (1991)
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Event Date 01/26/2021 |
Event Type
malfunction
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Event Description
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It was reported that this cardiac resynchronization therapy defibrillator (crt-d) and left ventricular (lv) lead showed loss of capture (loc) on the presenting electrogram (egm).In addition, there were multiple high out-of-range pace impedance spikes greater than 3,000 ohms, and it was suspected that the lead-to-head connection was the cause.Technical services (ts) recommended evaluating pace vectors that did not use the ring.Additional information received reported that the patient experienced phrenic nerve stimulation in every other configuration, which is why this vector had been chosen.Thresholds taken that day were 1.5v and output was set to 2v; the safety margin was later increased and trend was programmed on.A twelve lead echocardiogram (ecg) was taken, and capture was confirmed.This crt-d system remains in service and will continue to be monitored.No additional adverse patient effects were reported.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that this cardiac resynchronization therapy defibrillator (crt-d) and left ventricular (lv) lead showed loss of capture (loc) on the presenting electrogram (egm).In addition, there were multiple high out-of-range pace impedance spikes greater than 3,000 ohms, and it was suspected that the lead-to-head connection was the cause.Technical services (ts) recommended evaluating pace vectors that did not use the ring.Additional information received reported that the patient experienced phrenic nerve stimulation in every other configuration, which is why this vector had been chosen.Thresholds taken that day were 1.5v and output was set to 2v; the safety margin was later increased and trend was programmed on.A twelve lead echocardiogram (ecg) was taken, and capture was confirmed.This crt-d system remains in service and will continue to be monitored.No additional adverse patient effects were reported.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.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.Investigation has determined that this type of event is likely the result of an intermittent high impedance condition associated with the device spring contact and lead terminal ring.A design enhancement was implemented in 2020 to stabilize the electrical connection between the spring contact and the lead terminal.
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