BOSTON SCIENTIFIC CORPORATION VISIONIST X4 CRT-P; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
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Model Number U228 |
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 11/29/2018 |
Event Type
Injury
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Event Description
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It was reported that this device was exhibiting premature battery depletion.A decrease in the battery's longevity was observed, and was showing less than 3 months remaining.The lead measurements have remained stable since implant.A copy of device memory was saved and submitted to technical services (ts) for review of the battery.A ts consultant confirmed premature battery depletion.The diagnostic data showed that the power consumption has been increasing during the past year, and is expected to continue increasing.Due to this anomaly, replacement was recommended.This device currently remains implanted and in service.No adverse patient effects were reported.
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Event Description
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It was reported that this implantable device was exhibiting premature battery depletion behavior.A decrease in the battery's longevity was observed, and showing less than 3 months remaining.The lead measurements have remained stable since implant.A copy of device memory was saved and submitted to technical services (ts) for review of the battery.A ts consultant confirmed premature battery depletion.The diagnostic data showed that the power consumption has been increasing during the past year, and is expected to continue increasing.Due to this anomaly, replacement was recommended.This device currently remains implanted and in service.No adverse patient effects were reported.Additional information: several requests were submitted to the field to obtain additional information regarding this event.No response was provided.
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Manufacturer Narrative
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As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
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Manufacturer Narrative
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This device was not retained by the hospital, therefore is not available for return.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
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Event Description
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It was reported that this device was exhibiting premature battery depletion.A decrease in the battery's longevity was observed, and showing less than 3 months remaining.The lead measurements have remained stable since implant.A copy of device memory was saved and submitted to technical services (ts) for review of the battery.A ts consultant confirmed premature battery depletion.The diagnostic data showed that the power consumption has been increasing during the past year, and is expected to continue increasing.Due to this anomaly, replacement was recommended.Subsequently, this device was explanted and replaced.No additional adverse patient effects were reported.This device was not retained by the hospital for return.
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