D
Patient 1
THE PACE-SENSE PORTION OF THIS RV LEAD WAS CAPPED AND REPLACED DUE TO AN UNSPECIFIED MALFUNCTION. THE SHOCK PORTION OF THIS LEAD REMAINS ACTIVELY IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
MAUDE MDR 2876116
- MDR report key
- 2876116
- Report number
- 1028232-2012-02828
- Event key
- 0
- Event type
- 3
- Date of event
- 2012-06-15
- Date received
- 2012-11-07
- 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 | LINXO SD 65/16 | ICD LEAD | BIOTRONIK S & CO. KG | LWS | 350053 | 350053 | * | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2012-11-07 | 0 | 1. H |