Model Number U125 |
Device Problems
Signal Artifact/Noise (1036); High impedance (1291); Over-Sensing (1438); Under-Sensing (1661)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/12/2022 |
Event Type
malfunction
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Manufacturer Narrative
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This investigation will be updated should further pertinent information be provided.
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Event Description
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It was reported that this cardiac resynchronization therapy pacemaker (crt-p) recorded signal artifact monitoring episodes due to over sensing termination algorithm.There was also noisy signals over sensed even when the respiratory sensor was disabled and a lead safety switch alert due to high, out of range pacing impedances and also some signals were observed to be functionally blanked, therefore under sensed.Various programming options and a lead assessment were recommended.The system, which has non bsc leads, remains in service.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) that is related to intermittent increases in impedance measurements.Engineering analysis and testing of returned products has identified that any repeated, small movements of the lead terminal ring can create wearing of the lead terminal ring and generate microscopic particles, which may accumulate and oxidize over time.This can impact the connection between the spring contact and the lead ring, resulting in intermittent changes in impedance measurements.Please refer to the description field for more information regarding the specific circumstances of this event.This investigation will be updated should further pertinent information be provided.
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Event Description
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It was reported that this cardiac resynchronization therapy pacemaker (crt-p) recorded signal artifact monitoring episodes due to over sensing termination algorithm.There was also noisy signals over sensed even when the respiratory sensor was disabled and a lead safety switch alert due to high, out of range pacing impedances and also some signals were observed to be functionally blanked, therefore under sensed.Various programming options and a lead assessment were recommended.The system, which has non bsc leads, remains in service.No adverse patient effects were reported.
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Search Alerts/Recalls
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