BOSTON SCIENTIFIC CORPORATION INLIVEN; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
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Model Number W173 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
Device Overstimulation of Tissue (1991)
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Event Date 11/15/2022 |
Event Type
Injury
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Event Description
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It was reported that the patient with this pacemaker presented to the emergency room (er) due to phrenic nerve stimulation.Upon interrogation, the device was found to have reverted to safety mode.Subsequently, the patient underwent a revision procedure, and this device was explanted and replaced without incident.Besides intervention, there were no other adverse patient effects reported.Device return is expected.
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Manufacturer Narrative
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To date, this device has not been returned; therefore, technical analysis cannot be conducted.Without a returned device it is not possible to definitively confirm how the device may have contributed to the complaint incident.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that the patient with this pacemaker presented to the emergency room (er) due to phrenic nerve stimulation.Upon interrogation, the device was found to have reverted to safety mode.Subsequently, the patient underwent a revision procedure, and this device was explanted and replaced without incident.Besides intervention, there were no other adverse patient effects reported.This device has not been returned despite good faith efforts thus far.Should the device be returned in the future, laboratory analysis will be performed, and an updated report will be issued.
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Search Alerts/Recalls
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