Model Number 3660 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Unspecified Infection (1930)
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Event Date 07/06/2022 |
Event Type
Death
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Event Description
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It was reported that, following a procedure, the patient developed an infection due to their bowel rupturing.The patient then passed away a few days after.
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Manufacturer Narrative
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An event of infection was reported to abbott.It was determined the patient developed an infection due to their bowel rupturing.The patient then passed away a few days after.No explanted products were returned for analysis.As a result, a device history record was performed to review and confirm the sterility of the ipg.Based on the documents reviewed, the source of the infection is yet to be substantiated.
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Manufacturer Narrative
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As patient passed away due to a pre-existing condition, the record is no longer reportable.
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Event Description
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Additional information revealed that the patient passed away due to a pre-existing condition, not related to the device or procedure.
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Search Alerts/Recalls
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