Model Number G407209 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Stroke/CVA (1770)
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Event Date 09/09/2019 |
Event Type
Injury
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Manufacturer Narrative
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An event of a stroke was reported.The results of the investigation are inconclusive since the device was not returned for analysis. additionally, the device history record was unable to be reviewed as a lot number was not provided. based on the information received, the cause of the reported stroke could not be conclusively determined.
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Event Description
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Related manufacturing ref: 3005334138-2019-00551, 2182269-2019-00172, 2030404-2019-00102, 3005334138-2019-00552, 2182269-2019-00173.Following a left atrial pulmonary vein isolation procedure, a stroke occurred.No complications or patient symptoms were observed during the procedure.The patient is recovering.There were no performance issues with any abbott device.
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Manufacturer Narrative
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An event of a stroke was reported.The results of the investigation are inconclusive since the device was not returned for analysis. additionally, no lot number was provided so a review of the device history record (dhr) was not possible. based on the information received, the cause of the reported stroke could not be conclusively determined.
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Event Description
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Following a left atrial pulmonary vein isolation procedure, a stroke occurred.No complications or patient symptoms were observed during the procedure.Anticoagulation was required for the stroke.The patient is still in rehabilitation and is regaining speech as of (b)(6).There were no performance issues with any abbott device.
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Search Alerts/Recalls
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