Model Number G125 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Bacterial Infection (1735)
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Event Date 11/01/2023 |
Event Type
Injury
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Manufacturer Narrative
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The local area sales representative was contacted for additional information.At this time, no further information is available.Should additional information become available this report will be updated.
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Event Description
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It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) contacted boston scientific indicating that they allegedly had a staphylococcus aureus implant infection.At this time no further information is available, but additional details were requested to the field.No additional adverse patient effects were reported.Evidence suggests that the device remains implanted and in service.
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Event Description
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It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) contacted boston scientific indicating that they allegedly had a staphylococcus aureus implant infection.At this time no further information is available, but additional details were requested to the field.No additional adverse patient effects were reported.Evidence suggests that the device remains implanted and in service.Additional information was received.The device was explanted, and the leads remain implanted.No additional adverse patient effects were reported.
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Manufacturer Narrative
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Follow up report 2: date of event was corrected.
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Event Description
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It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) contacted boston scientific indicating that they allegedly had a staphylococcus aureus implant infection.At this time no further information is available, but additional details were requested to the field.No additional adverse patient effects were reported.Evidence suggests that the device remains implanted and in service.Additional information was received.The device was explanted, and the leads remain implanted.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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