D
Patient 1
OUS MDR - AFTER AN IMPLANTATION TIME OF 34 MONTHS, AN INSULATION DEFECT WAS REPORTED. NO DETERIORATION IN THE PT'S STATE OF HEALTH WAS REPORTED. THE DEVICE WAS EXPLANTED.
MAUDE MDR 2595298
- MDR report key
- 2595298
- Report number
- 1028232-2012-01330
- Event key
- 0
- Event type
- 3
- Date of event
- 2012-04-19
- Date received
- 2012-05-29
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- 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 | LINOX SD 65/18 | ICD LEAD | BIOTRONIK ST & CO. KG | LWS | 350054 | 350054 | * | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2012-05-29 | 0 | 1. H |
Event Narratives#
N
Patient 1
OUS MDR.