Model Number PARADYM RF SONR CRT-D 9770 |
Device Problem
Display or Visual Feedback Problem (1184)
|
Patient Problem
No Information (3190)
|
Event Date 10/24/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
The device involved in this mdr report is not approved in the united states; however, it is similar to a device manufactured by sorin that was cleared or approved by fda for marketing in the united states.
|
|
Event Description
|
Reportedly, during a follow-up on (b)(6) 2018, the summary tab of the device memory (aida) screen showed ten treated vt/vf episodes around (b)(6) 2018.No episode was stored and no other trace of those therapies could be found in the device memory.Moreover, the patient confirmed not feeling any arrhythmias or shocks delivered.
|
|
Manufacturer Narrative
|
Please refer to the attached investigation report.
|
|
Event Description
|
Reportedly, during a follow-up on 24 october 2018, the summary tab of the device memory (aida) screen showed ten treated vt/vf episodes around (b)(6) 2018.No episode was stored and no other trace of those therapies could be found in the device memory.Moreover, the patient confirmed not feeling any arrhythmias or shocks delivered.
|
|
Search Alerts/Recalls
|