Model Number U128 |
Device Problems
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 10/07/2017 |
Event Type
Injury
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Manufacturer Narrative
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At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.
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Event Description
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Boston scientific received information that this cardiac resynchronization therapy pacemaker (crt-p) 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.As a result, this crt-p was explanted and replaced.No additional adverse patient effects were reported.
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Manufacturer Narrative
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This cardiac resynchronization therapy pacemaker (crt-p) was thoroughly inspected and analyzed upon receipt at our quality assurance laboratory.Review of the device memory indicated that a telemetry system fault was recorded.The device case was opened to facilitate analysis of the internal components.Electrical testing and analysis isolated the product performance issue to an anomaly in the radio frequency (rf) mics module.This anomaly resulted in reported clinical observation(s).
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Search Alerts/Recalls
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