Model Number KORA 250 SR |
Device Problem
Pacing Inadequately (1442)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/24/2021 |
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, mri imaging was performed on the head and neck on (b)(6) 2021.The pacemkaer mode was changed to mri mode (voo 80 min-1), but during the mri imaging and irradiation, pacing was observed at around 100 min-1.The event was reproducible.It was confirmed that the mri imaging parameters were set according to conditional mri.
|
|
Event Description
|
Reportedly, mri imaging was performed on the head and neck on (b)(6) 2021.The pacemaker mode was changed to mri mode (voo 80 min-1), but during the mri imaging and irradiation, pacing was observed at around 100 min-1.The event was reproducible.It was confirmed that the mri imaging parameters were set according to conditional mri.
|
|
Manufacturer Narrative
|
Please refer to the attached analysis report.
|
|
Search Alerts/Recalls
|