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Model Number 405154 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Pneumothorax (2012)
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Event Date 09/14/2020 |
Event Type
Injury
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Manufacturer Narrative
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The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.
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Event Description
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Related manufacturer report numbers: 3005334138-2020-00458.Following an lv implant procedure, during follow-up in the clinic, a pneumothorax was seen on the left lung of the patient.The patient was hospitalized and remained in good condition.There were no performance issues with any abbott devices.
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Search Alerts/Recalls
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