Device product
CardioCommand, Inc. Transesophageal Cardiac Pacing and Recording System, Model 7A, REF 0101 - Product Usage: Indications for Use: - Temporary left atrial pacing to treat bradycardia, hypotension or AV junctional rhythm - Acceleration of heart rate as an alternative to exercise or drugs during diagnostic cardiac studies such as echocardiography or radionuclide ventriculography. - Antitachycardia pacing for cardioversion of supraventricular tachycardia (SVT), including atrial flutter and re-entrant atrial or atrioventricular paroxysmal tachycardia. - Esophageal electrocardiography for differential diagnosis of complex atrial arrhythmia
Z-1773-2019
Product summary
- Event
- Event 82803
- Status
- Terminated
- Classification
- Class III
- Quantity
- 5 units
- Official record key
device-enforcement:Z-1773-2019
Official wording
Reason: Possible corrosion of the battery contact(s).
Code information: Serial Numbers: 8059, 8060, 8022, 8063, 8211
Distribution pattern: US Nationwide distribution in the states of CT, VW, OH, IL, DE.
Derived failure modes
-
Unknown
Possible corrosion of the battery contact(s).