BOSTON SCIENTIFIC CORPORATION INOGEN X4 CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
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Model Number G148 |
Device Problems
Signal Artifact/Noise (1036); 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 10/09/2023 |
Event Type
malfunction
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Event Description
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It was reported that this cardiac resynchronization therapy defibrillator (crt-d) system recorded a beeping alert.Upon interrogation of the device, an out of range pacing impedance measurement greater than 3000 ohms was observed for the right atrial (ra) lead.It was mentioned that in-office measurements show in-range impedance values around 500 ohms and no noise, however, when the patient is pushing downwards, the pacing impedance jumps to greater than 3000 ohms and artefacts are observed.Technical services (ts) recommended system revision to check lead integrity and the device header connection.The crt-d system remains in service.No 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 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) system recorded a beeping alert.Upon interrogation of the device, an out of range pacing impedance measurement greater than 3000 ohms was observed for the right atrial (ra) lead.It was mentioned that in-office measurements show in-range impedance values around 500 ohms and no noise, however, when the patient is pushing downwards, the pacing impedance jumps to greater than 3000 ohms and artefacts are observed.Technical services (ts) recommended system revision to check lead integrity and the device header connection.The crt-d system remains in service.No adverse patient effects were reported.
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Search Alerts/Recalls
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