D
Patient 1
LOSS OF CAPTURE WAS NOTED ON THIS LEAD. THE PT WAS REFERRED TO AN ELECTRO PHYSIOLOGIST FOR CONSULTATION. RECORDS INDICATE THIS DEVICE WAS SUCCESSFULLY EXPLANTED (B)(6) 2011. SHOULD ADD?L INFO BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.
MAUDE MDR 2455915
- MDR report key
- 2455915
- Report number
- 1028232-2012-00235
- Event key
- 0
- Event type
- 3
- Date of event
- 2011-12-22
- Date received
- 2012-01-31
- 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 | KAINOX SL 75/16 | ICD LEAD | BIOTRONIK SE & CO. KG | LWS | 124218 | 124218 | * | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2012-01-31 | 0 | 1. H; 2. O |