Model Number L231 |
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 09/20/2022 |
Event Type
malfunction
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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.Investigation of the available information determined this device exhibited oversensing of noise generated by the minute ventilation (mv)/respiratory sensor that is related to a high impedance condition.Please see the description for more information regarding the specific circumstances of this event.This device was included in the minute ventilation sensor signal oversensing advisory population.
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Event Description
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It was reported that non-physiologic artifacts were recorded on both the right atrial (ra) and right ventricular (rv) channels.The involved leads were both non-boston scientific products.There were stored episodes with noise and oversensing.Technical services noted that the oversensing was related to the minute ventilation (mv) feature.The feature was deactivated by the signal artifact monitor (sam).Technical services reviewed the stored episodes and determined that both competitor leads showed strong signs of lead impairment, high impedance condition and non-physiologic artifacts.Troubleshooting recommendations were provided.At this time, this pacemaker and competitor leads remain in service and there were no adverse patient effects reported.
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Event Description
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It was reported that non-physiologic artifacts were recorded on both the right atrial (ra) and right ventricular (rv) channels.The involved leads were both non-boston scientific products.There were stored episodes with noise and oversensing.Technical services noted that the oversensing was related to the minute ventilation (mv) feature.The feature was deactivated by the signal artifact monitor (sam).Technical services reviewed the stored episodes and determined that both competitor leads showed strong signs of lead impairment, high impedance condition and non-physiologic artifacts.Troubleshooting recommendations were provided.At this time, this pacemaker and competitor leads remain in service and there were 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.Investigation of the available information determined this device exhibited oversensing of noise generated by the minute ventilation (mv)/respiratory sensor that is related to a high impedance condition.Please see the description for more information regarding the specific circumstances of this event.This device was included in the minute ventilation sensor signal oversensing advisory population.
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Search Alerts/Recalls
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