Model Number A219 |
Device Problems
High impedance (1291); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Failure to Read Input Signal (1581); Failure to Select Signal (1582)
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Patient Problem
Electric Shock (2554)
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Event Date 10/13/2019 |
Event Type
Injury
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Manufacturer Narrative
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The local area sales representative was contacted for additional information.At this time, no further information is available.Should additional information become available this report will be updated.
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Event Description
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It was reported that the patient implanted with this subcutaneous implantable cardioverter defibrillator (s-icd) was admitted to the intensive care unit following an inappropriate shock due to t-wave oversensing.Review of stored device memory noted a previous episode of shock therapy that showed a change in morphology and decreased amplitude measurements.Additionally, shock impedance measurements were noted to have increased from 81 ohms to 107 ohms.Boston scientific technical services (ts) recommended review of of the system placement.Review of the system under x-ray noted appropriate system placement.The patient was released from the hospital and was seen for an in clinic follow up a few days later.A stress test was performed and a new reference template was captured.Available information indicates this product remains implanted and in service.No additional adverse patient effects were reported.
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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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Event Description
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It was reported that the root cause of the high shock impedance measurements was not determined.
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Search Alerts/Recalls
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