Model Number L301 |
Device Problems
Failure to Capture (1081); High impedance (1291); Over-Sensing (1438); Pacing Problem (1439)
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Patient Problems
Syncope (1610); No Code Available (3191); Syncope/Fainting (4411)
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Event Date 11/29/2020 |
Event Type
Injury
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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.(b)(4).
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Event Description
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It was reported that this patient had experienced syncopal episodes and system evaluation was being performed.A review of the stored data identified the lead safety switch had been triggered due to a pacing impedance measurement greater than 2000 ohms on the right ventricular (rv) channel.No capture was observed in bipolar configuration; therefore, the lead was reprogrammed to unipolar configuration.A revision procedure was subsequently performed and the rv lead was removed from service and replaced.Additionally, it was reported that several years ago the associated atrial lead had been exhibiting out of range pacing impedance measurements.Fluoroscopy revealed a lead fracture.The lead was electrically abandoned at that time.No additional adverse patient effects were reported.
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Manufacturer Narrative
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This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Investigation of the available information determined this device exhibited oversensing of noise generated by the minute ventilation (mv)/respiratory sensor that is related to a high impedance condition.This device was included in the minute ventilation sensor signal oversensing advisory population.
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Event Description
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This supplemental report is being filed to update the investigation conclusion code and additional manufacturing narrative.
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Search Alerts/Recalls
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