Model Number G156 |
Device Problems
Signal Artifact/Noise (1036); Over-Sensing (1438); Impedance Problem (2950)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/31/2022 |
Event Type
malfunction
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Event Description
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It was reported that this cardiac resynchronization therapy defibrillator (crt-d) and right atrial (ra) lead exhibited noise with oversensing and triggered an alert due to an unspecified out-of-range ra pace impedance measurement.It was also noted that this right ventricular (rv) defibrillation lead exhibited consistent noise on the rv and shock channels due to the patient's left ventricular assist device (lvad), however it was noted that this noise was not oversensed.Ts recommended further evaluation of the ra lead.This crt-d system remains in service.No adverse patient effects were reported.
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Manufacturer Narrative
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The local area field representative was contacted for additional information.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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The local area field representative was contacted for additional information.If information is provided in the future, a supplemental report will be issued.-- 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 this cardiac resynchronization therapy defibrillator (crt-d) and right atrial (ra) lead exhibited noise with oversensing and triggered an alert due to an unspecified out-of-range ra pace impedance measurement.It was also noted that this right ventricular (rv) defibrillation lead exhibited consistent noise on the rv and shock channels due to the patient's left ventricular assist device (lvad), however it was noted that this noise was not oversensed.Ts recommended further evaluation of the ra lead.This crt-d system remains in service.No adverse patient effects were reported.
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Search Alerts/Recalls
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