Model Number U128 |
Device Problems
Over-Sensing (1438); Low impedance (2285)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/02/2019 |
Event Type
malfunction
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Manufacturer Narrative
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This device was included in the recent minute ventilation sensor signal oversensing advisory population.
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Event Description
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It was reported that this cardiac resynchronization therapy pacemaker (crt-p) device exhibited two (2) signal artifact monitor (sam) events on the same day due to noise and oversensing of the minute ventilation (mv) sensor.This resulted in the mv sensor being automatically disabled by the device.Review of electrograms indicated both events exhibited noise on both the right atrial (ra) and right ventricular (rv) channels.It was also noted that the rv lead exhibited a corresponding low out of range pace impedance measurement less than 200 ohms.The rv lead is not a boston scientific product.The daily impedance measurements were indicated to be stable.Boston scientific technical service (ts) recommended to the healthcare provider (hcp) to keep the rate response trend (rrt) feature programmed off.The products remain in-service.No patient symptoms or 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.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 recent minute ventilation sensor signal oversensing advisory population.
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Event Description
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It was reported that this cardiac resynchronization therapy pacemaker (crt-p) device exhibited two (2) signal artifact monitor (sam) events on the same day due to noise and oversensing of the minute ventilation (mv) sensor.This resulted in the mv sensor being automatically disabled by the device.Review of electrograms indicated both events exhibited noise on both the right atrial (ra) and right ventricular (rv) channels.It was also noted that the rv lead exhibited a corresponding low out of range pace impedance measurement less than 200 ohms.The rv lead is not a boston scientific product.The daily impedance measurements were indicated to be stable.Boston scientific technical service (ts) recommended to the healthcare provider (hcp) to keep the rate response trend (rrt) feature programmed off.The products remain in-service.No patient symptoms or adverse patient effects were reported.
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Search Alerts/Recalls
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