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Model Number 1000 |
Device Problem
Inappropriate or Unexpected Reset (2959)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/22/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Livanova usa, inc.Submits this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation, based on information that livanova has obtained, but may not have been able to investigate or verify prior to the date the report was required by the fda.This report does not constitute an admission, or a conclusion by fda or anyone else, that the device, livanova, or livanova's employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects¿ or "malfunctions¿.These words are incorporated into the fda 3500a medwatch form by the fda, and livanova objects to their use.
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Event Description
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It was reported that during a battery replacement, when interrogating the new replacement generator, error code 14 (generator disabled due to brown-out-reset) was observed.Per the report, the error code was seen when the generator was taken out of the package, and it was not suspected that the device was exposed to any electrocautery as the error code was seen before being implanted.After re-enabling therapy, when the device was re-interrogated, diagnostics were all ok and the generator was implanted.Tablet data was provided for review.No other relevant information has been received to date.
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Event Description
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Information was received from the surgeon that the device was stored inside its sterile package and that the storage temperature prior to surgery was "body temperature" (i.E.Normal).
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Event Description
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Additional information was received reporting that the patient was recently seen by their neurologist and diagnostics were within normal limits.No additional report of resets.No other relevant information has been received to date.
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Manufacturer Narrative
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This report was due on november 25th, 2023; however, due to a network disruption at livanova, the ability to submit mdrs was lost on november 20, 2023, before this report was ready to submit.The report was prepared and submitted immediately following restoration of the livanova systems.
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Search Alerts/Recalls
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