Model Number T180 |
Device Problem
Inappropriate/Inadequate Shock/Stimulation (1574)
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Patient Problem
Arrhythmia (1721)
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Event Date 10/25/2014 |
Event Type
malfunction
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Event Description
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Boston scientific received information that the patient with this implantable cardioverter defibrillator (icd) received inappropriate therapy because the device missed an atrial event due to premature ventricular contraction (pvc) with noted therapy exhaustion.Additional information indicates that there was no plan of a device change out.As a result, the device was reprogrammed to resolve the issue.The icd remains in service.No adverse patient effects were reported.
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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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Event Description
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Additional information indicates that the device was explanted due to normal battery depletion.No adverse patient effects were reported.
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Manufacturer Narrative
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(b)(4).Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the device was performed.The allegation against the device was not confirmed.The device was put through and passed the therapy verification test which involves series of automated diagnostic testing that verifies the performance of pacing, sensing, and shocking functions of the device commensurate with battery voltage.The device meets specification and normal battery depletion was noted.
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Search Alerts/Recalls
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