Model Number EP003994S |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Arrhythmia (1721); Death (1802)
|
Event Date 07/05/2019 |
Event Type
Death
|
Manufacturer Narrative
|
Concomitant medical products: mapping catheter, 990045 guide wire, 990061-070 sheath.Product event summary: the data files were returned however they were corrupted and unable to be opened.The clinical issues reported would not have been confirmed through the data files.The physical product was not returned for investigation.If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
It was reported that immediately after a successful cryo ablation procedure, the patient experienced bradycardia.The patient was then paced.A cardiac massage and pericardiocentesis were performed and two hours of pharmacological treatments were administered.The patient is deceased.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
It was further reported the physician noted the patient "probably had a coronaropathy "by stander" and the death was caused by electromechanical dissociation.".
|
|
Search Alerts/Recalls
|