BOSTON SCIENTIFIC CORPORATION DYNAGEN CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
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Model Number G150 |
Device Problems
High impedance (1291); Noise, Audible (3273)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/29/2020 |
Event Type
malfunction
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Event Description
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It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was emitting tones.The device and a non boston scientific right atrial (ra) lead exhibited impedance measurements of greater than 3000 ohms.The device would be reprogrammed, and the patient would continue to be monitored.No adverse patient effects were reported.The device remains in service.
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Event Description
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It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was emitting tones.The device and a non boston scientific right atrial (ra) lead exhibited impedance measurements of greater than 3000 ohms.The device would be reprogrammed, and the patient would continue to be monitored.No adverse patient effects were reported.The device remains in service.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's 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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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's 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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