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 03/26/2024 |
Event Type
malfunction
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Event Description
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It was reported that the pacemaker was exhibiting premature battery depletion (pbd).Data analysis was performed, and boston scientific technical services indicated that the power consumption in this device is increasing abnormally.Technical services recommended device replacement due to this anomaly.The pbd is still at an early stage, the healthcare professional can still maximize patient implant time before device replacement.The healthcare professional can provide new data in a few months for re-evaluation for a new replacement window.No adverse patient effects were reported.The device remains in-service.
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Event Description
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It was reported that the pacemaker was exhibiting premature battery depletion (pbd).Data analysis was performed, and boston scientific technical services indicated that the power consumption in this device is increasing abnormally.Technical services recommended device replacement due to this anomaly.The pbd is still at an early stage, the healthcare professional can still maximize patient implant time before device replacement.The healthcare professional can provide new data in a few months for re-evaluation for a new replacement window.No adverse patient effects were reported.The device remains in-service.
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Search Alerts/Recalls
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