Model Number G125 |
Device Problems
High impedance (1291); Noise, Audible (3273)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/24/2022 |
Event Type
malfunction
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Event Description
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It was reported that this cardiac resynchronization therapy defibrillator (crt-d) emitted audible tones due to exhibiting high out of range pacing impedance measurements from the right ventricular channel, eventually the values went back to normal measurements.Further monitoring of the patient was discussed.This device remains in service.No further adverse patient effects were reported.
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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 complaint 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 this cardiac resynchronization therapy defibrillator (crt-d) emitted audible tones due to exhibiting high out of range pacing impedance measurements from the right ventricular channel, eventually the values went back to normal measurements.Further monitoring of the patient was discussed.This device remains in service.No further adverse patient effects were reported.
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Search Alerts/Recalls
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