BOSTON SCIENTIFIC CORPORATION INOGEN X4 CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
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Model Number G146 |
Device Problem
High impedance (1291)
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Patient Problem
Device Overstimulation of Tissue (1991)
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Event Date 05/12/2021 |
Event Type
malfunction
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Manufacturer Narrative
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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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Event Description
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It was reported that the patient implanted with this cardiac resynchronization therapy defibrillator (crt-d) and left ventricular (lv) lead was seen in office for diaphragmatic stimulation.In addition, lv pace impedance trends showed variable impedance measurements that increased to high out-of-range values that remain greater than 3,000 ohms.Ts recommended further evaluation with isometrics.This crt-d and lv lead remain in service.No additional adverse patient effects were reported.
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