BOSTON SCIENTIFIC CORPORATION DYNAGEN CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
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Model Number G151 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Staphylococcus Aureus (2058); No Code Available (3191)
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Event Date 06/01/2020 |
Event Type
Injury
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Manufacturer Narrative
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The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental report will be filed.(b)(4).
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Event Description
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It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) had an infection.Reportedly, the patient developed staphylococcus aureus infection.All available information indicates that the crtd along with three non-boston scientific leads were explanted.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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