Model Number A219 |
Device Problems
Signal Artifact/Noise (1036); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Failure to Read Input Signal (1581); Failure to Select Signal (1582); Device Sensing Problem (2917); Data Problem (3196)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
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Event Date 12/14/2018 |
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.
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Event Description
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It was reported that smart pass had been disabled and this caller was requesting assistance to program it back on.A boston scientific technical services consultant instructed the caller and smart pass was re-enabled.The caller reported appropriate sensing; however, a review of the stored data identified noise and oversensing resulted in inappropriate shocks on more than one occasion.The consultant documented and discussed the clinical observations with the caller.Additional troubleshooting was recommended.No adverse patient effects were reported.
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Event Description
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It was reported that this system was explanted and replaced.No additional adverse patient effects were reported.
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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.The 3191 code was utilized due to the surgery that occurred.
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Search Alerts/Recalls
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