BOSTON SCIENTIFIC CORPORATION ESSENTIO MRI EL DR; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
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Model Number L131 |
Device Problems
Premature Discharge of Battery (1057); Battery Problem (2885)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/25/2024 |
Event Type
malfunction
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Event Description
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It was reported that a request was made to have data from this pacemaker analyzed as the estimated remaining battery longevity was less than expected.Data analysis showed the battery consumption had been increasing at an unexpected rate, and a technical services consultant recommended device replacement or repeat data analysis.At this time, there is no evidence to suggest intervention has been performed.No adverse patient effects were reported.
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Manufacturer Narrative
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This device remains implanted; therefore, technical analysis cannot be conducted.If pertinent information is provided in the future, a supplemental report will be submitted.
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Event Description
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It was reported that a request was made to have data from this pacemaker analyzed as the estimated remaining battery longevity was less than expected.Data analysis showed the battery consumption had been increasing at an unexpected rate, and a technical services consultant recommended device replacement or repeat data analysis.At this time, there is no evidence to suggest intervention has been performed.No adverse patient effects were reported.To date, no additional information has been received.Should additional follow-up information be provided in the future, an updated report will be issued.
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Search Alerts/Recalls
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