Model Number 106 |
Device Problem
Scratched Material (3020)
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Patient Problems
Wound Dehiscence (1154); Seizures (2063)
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Event Date 05/04/2016 |
Event Type
Injury
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Manufacturer Narrative
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Suspect medical device udi: (b)(4).
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Event Description
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It was reported that the generator site was open and the generator was exposed.The patient was recently implanted on (b)(6) 2016.The patient was then referred for surgery to irrigate the site and close the incision.Further follow-up found that the patient has a history of picking at his skin during a seizure.The patient reported to the neurologist that he had a seizure and afterwards the generator incision was found to be open.The patient underwent surgery where the incision site was irrigated with antibiotic solution and the incision was closed.The generator was not replaced during this surgery.No additional relevant information has been received to date.
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Manufacturer Narrative
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Device evaluated by mfr?, device evaluation is not necessary as infection is not related to the functionality or delivery of therapy of the device.
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Event Description
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It was reported that the patient's generator and lead were explanted due to infection.Device evaluation is not necessary as infection is not related to the functionality or delivery of therapy of the device no further relevant information has been received to date.
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Manufacturer Narrative
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Describe event or problem , corrected data: the manufacturer's device history records review for sterility was inadvertently omitted from supplemental mdr 1.Type of investigation, corrected data: (b)(4).
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Event Description
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The manufacturer's device history records of the lead and generator were reviewed.The sterility of the lead and generator prior to release was verified.
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Search Alerts/Recalls
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