Model Number 0673 |
Device Problem
No Apparent Adverse Event (3189)
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Patient Problems
Hematoma (1884); Cardiac Tamponade (2226); Cardiac Perforation (2513)
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Event Date 02/22/2023 |
Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that during a routine follow up it was found out that the patient with this right ventricular (rv) lead had perforation, cardiac tamponade and bleeding or hematoma, which was confirmed through echocardiogram.An emergent pericardiocentesis was then performed.Further, the physician then opted to remove the lead and implanted new lead.No additional adverse patient effects were reported.
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Event Description
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It was reported that during a routine follow up it was found out that the patient with this right ventricular (rv) lead had perforation, cardiac tamponade and bleeding or hematoma, which was confirmed through echocardiogram.An emergent pericardiocentesis was then performed.Further, the physician then opted to remove the lead and implanted new lead.No additional adverse patient effects were reported.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The related investigation determined that this lead was associated with a reported perforation with no conclusive evidence of a malfunction; please refer to the description for more information regarding the specific circumstances of this event.
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Search Alerts/Recalls
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