D
Patient 1
THIS LEAD WAS REMOVED AND REPLACED DUE TO NON-CAPTURE. THERE WERE NO ADVERSE PT EVENTS REPORTED. THE HOSPITAL RETAINED THE DEVICE. SHOULD ADD'L INFO BE RECEIVED, THIS FILE WILL BE UPDATED.
MAUDE MDR 2956497
- MDR report key
- 2956497
- Report number
- 1028232-2013-00046
- Event key
- 0
- Event type
- 3
- Date of event
- 2012-11-09
- Date received
- 2013-01-15
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 2
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Address
- 6024 JEAN ROAD LAKE OSWEGO OR 97035 US
- Phone
- 877-877-8772
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | SETROX S 53 | PACER LEAD | BIOTRONIK SE & CO. KG | NVZ | 350974 | 350974 | * | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2013-01-15 | 0 | 1. H |