Model Number 439688 |
Device Problems
Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); Vascular Dissection (3160)
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Event Date 06/27/2018 |
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 the implant procedure, the patient's coronary vein was torn causing the patient to experience ventricular fibrillation (vf).The left ventricular (lv) lead was attempted and not used.No further patient complications have been reported as a result of this event.
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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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Search Alerts/Recalls
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