D
Patient 1
THIS LEAD WAS CAPPED AND REPLACED DUE TO A TOTAL LOSS OF CAPTURE AND A POSSIBLE LEAD FRACTURE. SHOULD ADD?L INFO BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
MAUDE MDR 2578484
- MDR report key
- 2578484
- Report number
- 1028232-2012-01239
- Event key
- 0
- Event type
- 3
- Date of event
- 2010-08-03
- Date received
- 2012-05-11
- 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 | SELOX ST 53 | PACER LEAD | BIOTRONIK SE & CO. KG | DXY | 346366 | 346366 | * | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2012-05-11 | 0 | 1. H |