Model Number G124 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Hematoma (1884); Hemorrhage/Bleeding (1888)
|
Event Date 06/14/2023 |
Event Type
Injury
|
Event Description
|
It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) had a large hematoma the day after this device was implanted.The hematoma was evacuated.This device remains in service.No additional adverse patient effects were reported.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) had a large hematoma the day after this device was implanted.The hematoma was evacuated.This device remains in service.No additional adverse patient effects were reported.Additional information was received indicating that the cause of hematoma was due to bleeding.This device remains in service.No additional adverse patient effects were reported.
|
|
Search Alerts/Recalls
|