BOSTON SCIENTIFIC CORPORATION INOGEN CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
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Model Number G141 |
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 01/04/2023 |
Event Type
malfunction
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Manufacturer Narrative
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If pertinent information is provided in the future, a supplemental report will be submitted.
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Event Description
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It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited beeping tones.Device programming had been performed, which temporarily stopped the beeping for a few days.Multiple previous pace impedance measurements of greater than 3,000 ohms were observed, some abrupt.Technical services (ts) discussed troubleshooting options.This crt-d remains in service.No adverse patient effects 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 product performance issue 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 this cardiac resynchronization therapy defibrillator (crt-d) exhibited beeping tones.Device programming had been performed, which temporarily stopped the beeping for a few days.Multiple previous pace impedance measurements of greater than 3,000 ohms were observed, some abrupt.Technical services (ts) discussed troubleshooting options.This crt-d remains in service.No adverse patient effects reported.
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Search Alerts/Recalls
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