D
Patient 1
THIS LEAD WAS CAPPED AND REPLACED DUE TO NO SENSING AND HIGH CAPTURE THRESHOLD. THERE WERE NO ADVERSE EVENTS REPORTED FOR THE PT. SHOULD MORE INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.
MAUDE MDR 2753689
- MDR report key
- 2753689
- Report number
- 1028232-2012-02252
- Event key
- 0
- Event type
- 3
- Date of event
- 2012-07-17
- Date received
- 2012-09-17
- 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 60 | PACER LAED | BIOTRONIK SE & CO. KG | LWS | 350975 | 350975 | * | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2012-09-17 | 0 | 1. H |