Model Number U128 |
Device Problems
High impedance (1291); Over-Sensing (1438)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)
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Event Date 12/01/2020 |
Event Type
malfunction
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Event Description
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It was reported that a signal artifact monitor episode was noted.Boston scientific technical services reviewed the stored information and it was determined the noise appeared consistent with minute ventilation sensor oversensing.High out of range right atrial (ra) lead impedance measurements were also noted for another manufacturer's lead and this cardiac resynchronization therapy pacemaker (crt-p).Ts discussed that the impedance measurements have been fluctuating over the last couple of months and suggested turning off the rate response trend feature on the crt-p it was thought that this was to do with slight movement of the lead in the header of the crt-p.The device and lead remain in service and 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.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.
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Event Description
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It was reported that a signal artifact monitor episode was noted.Boston scientific technical services reviewed the stored information and it was determined the noise appeared consistent with minute ventilation sensor oversensing.High out of range right atrial (ra) lead impedance measurements were also noted for another manufacturer's lead and this cardiac resynchronization therapy pacemaker (crt-p).Ts discussed that the impedance measurements have been fluctuating over the last couple of months and suggested turning off the rate response trend feature on the crt-p it was thought that this was to do with slight movement of the lead in the header of the crt-p.The device and lead remain in service and no adverse patient effects were reported.
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Search Alerts/Recalls
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