N
Patient 1
EVENT DATE IS APPROXIMATED SINCE UNKNOWN.
MAUDE MDR 9873953
- MDR report key
- 9873953
- Report number
- 2134265-2020-03786
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-02-01
- Date received
- 2020-03-24
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- JAY JOHNSON
- Address
- TWO SCIMED PLACE MAPLE GROVE MN 55311 US
- Phone
- 763-763-7634
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | WATCHMAN FLX LAA CLOSURE DEVICE & DELIVERY SYSTEM | SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL | BOSTON SCIENTIFIC CORPORATION | NGV | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-24 | 0 | 1. O |
Event Narratives#
D
Patient 1
IT WAS REPORTED VIA ABSTRACT PRESENTATION THAT THROMBUS ON THE DEVICE OCCURRED. AT AN UNKNOWN TIME, A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED. A WATCHMAN FLX LAA CLOSURE DEVICE WAS IMPLANTED. AT THE PATIENT'S THREE MONTH FOLLOW UP TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE), A THROMBUS WAS NOTED ON THE DEVICE.