Catalog Number M003EZAS30240 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Headache (1880); Paralysis (1997); Loss of Vision (2139)
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Event Date 02/27/2017 |
Event Type
Injury
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Manufacturer Narrative
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Device remains in patient.
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Event Description
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It was reported after the procedure the patient suffered a migraine and hlh + left hemiplegia.The event resolved without sequelae.The patients medical condition was good.There were no clinical consequences to the patient.
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Event Description
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It was reported after the procedure the patient suffered a migraine and hlh + left hemiplegia.The event resolved without sequelae.The patients medical condition was good.There were no clinical consequences to the patient.
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Manufacturer Narrative
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The device was not returned as it remains implanted in patient.Due to the automated mes/dhr system there are controls in the manufacturing process to ensure the product met specifications upon release.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.Based upon medical review, the harm observed in the complaint is anticipated in nature as per the device risk assessment.The reported event was unable to be confirmed and it cannot be confirmed that the device net specification, as the device was not returned.An assignable cause of anticipated procedural complication will be assigned to the reported event as a product related root cause does not apply and the issue is due to a known physiological effect of the procedure and/or patient condition noted with the directions for use, product labeling and/or risk documentation files.
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Search Alerts/Recalls
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