Model Number T180 |
Device Problems
Device Alarm System (1012); High impedance (1291)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/02/2014 |
Event Type
Injury
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Event Description
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Boston scientific received information that this implantable cardioverter defibrillator (icd) and implantable defibrillation lead exhibited a high out of range shock impedance measurement greater than 125 ohms.Available information indicates that this product remains implanted and in service.No adverse patient effects were reported.
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Manufacturer Narrative
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(b)(4).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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Additional information was received that the device emitted beeping tones.Review of stored device memory revealed that the stored clinical event for the previous out of range shock impedance measurement was not properly cleared from the device, which, resulted in the tones.No new out of range measurements were observed.Boston scientific technical services (ts) discussed how to clear the clinical event.
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Manufacturer Narrative
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(b)(4).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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Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the device was performed.A visual inspection of the device header and case noted no anomalies.The device was then exposed to simulated heart load conditions, and the defibrillation, pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Laboratory analysis did not confirm the reported clinical observations.
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Event Description
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Additional information was received that the device was explanted and returned for analysis.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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