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Model Number 1000-D |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Wound Dehiscence (1154); Impaired Healing (2378); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 02/05/2024 |
Event Type
Injury
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Manufacturer Narrative
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F10 health effect, clinical code: code e2402 utilized; proposed second level coding - protrusion to capture incidents of a device being visible under the skin.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 in pre-op for a surgery unrelated to vns therapy, the hospital staff noticed a quarter-sized scab on the patient¿s chest.The surgeon offered to open and clean the scab since the patient would already be anesthetized.After this procedure, the patient¿s mother noticed the wound was not healing properly, so the patient was taken to a wound care specialist.They advised bandages and activated charcoal.After using these bandages, patient¿s mother noticed leads were protruding near where the wound that had been cleaned.Patient is scheduled for surgery to re-open, debride, wash, and close the wound and check the lead integrity.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.
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Event Description
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It was later reported that the patient was scheduled for system removal due to wound dehiscence.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.
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Search Alerts/Recalls
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