Model Number 1458Q/86 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pleural Effusion (2010); Pneumothorax (2012); Cardiac Perforation (2513)
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Event Date 12/12/2016 |
Event Type
Injury
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Manufacturer Narrative
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Udi: (b)(4).The results of the investigation are inconclusive since the device was not returned for analysis.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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During post implant follow-up, patient presented with tachypnea and a chest x-ray revealed a pneumothorax.A cardiac perforation and effusion were noted and a pleural tube was inserted.The perforation was suspected to have occurred during the implant procedure.Following the procedure, the event was resolved and the patient was in good condition.
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Event Description
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During post implant follow-up, patient presented with tachypnea and a chest x-ray revealed a pneumothorax.A lung perforation and effusion were noted and a pleural tube was inserted.The perforation was suspected to have occurred during the implant procedure.Following the procedure, the event was resolved and the patient was in good condition.
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Search Alerts/Recalls
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