Model Number L331 |
Device Problems
Pacing Problem (1439); Migration (4003)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/09/2022 |
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.The associated investigation determined that this device appeared to exhibit instances where the minute ventilation (mv) sensor did not respond as expected at higher rates.Please refer to 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 the minute ventilation (mv) sensor in this pacemaker did not work as expected when the patient was performing the rowing movement, nonetheless, in other activities is working as expected.The health care professional (hcp) wonder if the pacemaker could be moving in the pocket.Technical services (ts) suggested having the patient hold off on rowing type motion for several weeks and give pocket time to adjust to the pacemaker.This pacemaker remains in service.No adverse patient effects were reported.
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Event Description
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It was reported that the minute ventilation (mv) sensor in this pacemaker did not work as expected when the patient was performing the rowing movement, nonetheless, in other activities is working as expected.The health care professional (hcp) wonder if the pacemaker could be moving in the pocket.Technical services (ts) suggested having the patient hold off on rowing type motion for several weeks and give pocket time to adjust to the pacemaker.Additional information was received which indicated that the patient was in clinic for a follow up.It was noted that during biking the mv feature performed as expected, nonetheless, during activities of daily living (adl) when involving shoulder exercises, the sensor overreacts.Ts recommended changing the ventilatory threshold.This pacemaker 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.The associated investigation determined that this device appeared to exhibit instances where the minute ventilation (mv) sensor did not respond as expected at higher rates.Please refer to the description for more information regarding the specific circumstances of this event.
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Search Alerts/Recalls
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