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Model Number 1000 |
Device Problems
False Alarm (1013); High impedance (1291)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/30/2018 |
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 found from programming history database periodic review that patient was seen with high impedance.Device history records were reviewed.The lead was seen to pass all functional and quality testing prior to distribution.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.
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Manufacturer Narrative
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D1.Brand name, d2.Type of device, d4.Model #, serial #, lot #, expiration date, unique identifier, d6a.If implanted, give date (mo/day/yr), h4.Device manufacture date (mo/day/yr) h6.Adverse event problem codes - investigation findings, h6.Adverse event problem - investigation conclusions, corrected data; initial mdr inadvertently omitted information known prior to submission.
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Search Alerts/Recalls
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