ST. JUDE MEDICAL TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ BID CURVE F-J; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
|
Back to Search Results |
|
Model Number A-TCSE-FJ |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Nerve Damage (1979); Pericarditis (4448); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/14/2022 |
Event Type
Injury
|
Event Description
|
The patient presented to the hospital approximately 11 weeks post procedure with progressively worsening dyspnea and difficulty breathing.The patient was treated for pericarditis with medication.Possible phrenic nerve injury following an ablation procedure.
|
|
Event Description
|
Additional information received indicated this event is no longer reportable as the ae was submitted for the incorrect patient.The rc entered the data incorrectly.
|
|
Manufacturer Narrative
|
Additional information: b5, g3, h2, h3 the results of the investigation are inconclusive since the device was not returned for analysis.Review of the device history record was not possible as the lot number is unknown.Based on the information received, the cause of the reported pericarditis remains unknown.
|
|
Search Alerts/Recalls
|
|
|