D
Patient 1
THIS PATIENT'S RV LEAD WAS HAVING SENSING ISSUES AND THE PATIENT EXPRESSED THE DESIRE TO HAVE THE ENTIRE SYSTEM EXPLANTED AND NOT REPLACED. WHEN THE SYSTEM CAME OUT, IT WAS NOTED THE RV LEAD HAD BEEN SUBJECTED TO CLAVICULAR CRUSH.
MAUDE MDR 2299606
- MDR report key
- 2299606
- Report number
- 1028232-2011-02306
- Event key
- 0
- Event type
- 3
- Date of event
- 2011-09-23
- Date received
- 2011-10-10
- 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 | LUMAX 340 DR-T | ICD | BIOTRONIK SE & CO. KG | LWS | 355267 | 355267 | * | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2011-10-10 | 0 | 1. H |