D
Patient 1
THIS DEVICE WAS EXPLANTED BECAUSE, IT IS AT EOS INDICATION DUE TO INTERMITTENT OVERSENSING, NOISE AND SEVERAL SHOCKS ON THE RV LEAD. THE PHYSICIAN SPECULATES THAT THERE MIGHT HAVE BEEN A LEAD FRACTURE.
MAUDE MDR 1976627
- MDR report key
- 1976627
- Report number
- 1028232-2011-00197
- Event key
- 0
- Event type
- 3
- Date of event
- 2010-12-24
- Date received
- 2011-01-27
- 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 VR-T | ICD | BIOTRONIK SE & CO. KG | LWS | 355271 | 355271 | * | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2011-01-27 | 0 | 1. H |