While analysis was unable to be performed as the device was not returned, per the opinion of the physician, the root cause of the event was due to the ipg not being sutured into the pocket at the initial implant leading to device migration.The device history and sterilization record for this device serial number has been reviewed.No issues or discrepancies were noted during this review that would have contributed to the reported event.The device met material, assembly, and quality control requirements.Cvrx id# (b)(4).
|
A barostim system was implanted on (b)(6) 2023.Since implant, the patient experienced pain at the ipg pocket location.On (b)(6) 2023, the patient was seen by the surgeon due to possible device migration and ongoing implant site pain.A pocket revision occurred on (b)(6) 2023.It was noted that the ipg was not sutured during the initial implant, and the ipg had migrated up towards the clavicle.A second pocket was created and the ipg was sutured in using two sutures.The patient stated that there was a positive difference in how the site felt post revision.No additional intervention was planned.
|