Model Number ENSITE-AMP-02 |
Device Problem
Display or Visual Feedback Problem (1184)
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Patient Problem
Heart Block (4444)
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Event Date 03/16/2022 |
Event Type
Injury
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Event Description
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During a supraventricular tachycardia procedure, the patient experienced 2nd degree heart block.Three fixed curve catheters and one steerable decapolar catheter was placed inside the right atrium.Resp.Comp.Was applied and the catheters shifted multiple times.The heart block was transient in nature and the patient stabilized shortly thereafter.
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Manufacturer Narrative
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The navx study data was provided and reviewed.The reported event stated that ¿the catheters shifted multiple times¿.Review of the study was unable to confirm the shift, however the description of the event is consistent with a catheter display shift.Review of the ensite cardiac mapping system verifies that in some cases a catheter display shift can occur.If a shift occurs, it is recommended to use enguide alignment to return the catheters to their previous positions relative to the model.See ensite cardiac mapping system ifu, setup, enguide alignment.The cause of the reported heart block remains unknown.
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Event Description
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During a supraventricular tachycardia procedure with the use of conscious sedation, the patient experienced 2nd degree heart block during one of the cryo ablations with a non-abbott device.Three fixed curve catheters and one steerable decapolar catheter was placed inside the right atrium.Resp.Comp.Was applied and the catheters shifted multiple times.The heart block was transient in nature and the patient stabilized shortly thereafter.
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Search Alerts/Recalls
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