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Model Number 1000 |
Device Problem
Failure to Interrogate (1332)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/07/2023 |
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 return to clinic of the patient, the generator was not able to be interrogated.It was noted that troubleshooting was performed in the form of hard resetting wand and tablet, re-positioning wand, direct connection of wand and tablet via usb, re-inserting batteries, and utilizing a second set of programming system.Despite these troubleshooting steps, the device was still unable to be interrogating, noting a "generator not found" message.Device history records were reviewed for the device.The device passed all functional specifications and quality tests and was hp sterilized prior to distribution.No other relevant information has been received to date.
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Event Description
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Additional information received noting that the patient underwent a battery replacement due to battery depletion.The explanted generator has not been received by product analysis to date.
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Search Alerts/Recalls
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