Model Number N107 |
Device Problems
Device Alarm System (1012); Premature Discharge of Battery (1057); Device Displays Incorrect Message (2591)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/25/2015 |
Event Type
malfunction
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Manufacturer Narrative
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This investigation will be updated should further information be provided.
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Event Description
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Boston scientific received information that this cardiac resynchronization therapy defibrillator (crt-d) emitted tones and recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.Data analysis showed the battery appeared to be depleting more quickly than expected.Device replacement was recommended.This crt-d remains in service.No adverse patient effects were reported.Boston scientific has issued an advisory communication regarding an older subset of cognis/teligen devices that is more susceptible to a product performance anomaly.Specifically, the performance of a low voltage capacitor may be compromised over time, causing an increased current drain that can lead to premature battery depletion.This particular device was included in the advisory population.
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Manufacturer Narrative
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The product is expected to be returned for analysis.This report will be updated upon return and completion of analysis.
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Event Description
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Additional information was received that indicated this device was explanted.No additional adverse patient effects were reported.
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Manufacturer Narrative
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This device was thoroughly inspected and analyzed upon receipt at our quality assurance laboratory.Review of the device memory indicated that a low voltage alert, code 1003, was recorded.The battery voltage was lower than expected, but still supported full device function.Using historical daily battery voltage measurement data, engineers determined that this device was demonstrating behavior consistent with a high current condition associated with a compromised low voltage capacitor connected to the device's battery.Low voltage capacitors are used in the device's high voltage charging operation in order to facilitate fast charge times.Malfunction of these capacitors resulted in a high current drain, which was depleting this device's battery faster than normal.
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Search Alerts/Recalls
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