Model Number U125 |
Device Problems
Failure to Capture (1081); High impedance (1291); Over-Sensing (1438)
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Patient Problem
Syncope (1610)
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Event Date 10/12/2020 |
Event Type
Injury
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Event Description
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It was reported that boston scientific technical services (ts) received a call from a health care professional (hcp) about loss of capture with nine seconds of asystole and variable impedances within normal limits on the right ventricular (rv) and left ventricular (lv) leads.The patient was in the hospital because of an ablation procedure they had done the day before.The patient experienced some presyncope.It was noted that the signal artifact monitor (sam) had disabled the device's minute ventilation (mv) sensor.Ts suspected a spring contact issue, programming options were discussed and the device was reprogrammed.It was recommended to monitor the patient for twenty-four hours post programming changes.This device was included in the recent minute ventilation sensor signal oversensing advisory population, which ts discussed with the hcp.The device and leads remain in service.No additional adverse patient effects were reported.
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Event Description
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It was reported that boston scientific technical services (ts) received a call from a health care professional (hcp) about loss of capture with nine seconds of asystole and variable impedances within normal limits on the right ventricular (rv) and left ventricular (lv) leads.The patient was in the hospital because of an ablation procedure they had done the day before.The patient experienced some presyncope.It was noted that the signal artifact monitor (sam) had disabled the device's minute ventilation (mv) sensor.Ts suspected a spring contact issue, programming options were discussed and the device was reprogrammed.It was recommended to monitor the patient for twenty-four hours post programming changes.This device was included in the recent minute ventilation sensor signal oversensing advisory population, which ts discussed with the hcp.The device and leads remain in service.No additional 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 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's 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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Search Alerts/Recalls
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