MAUDE MDR 50941413
- MDR report key
- 50941413
- Report number
- 2124215-2026-51894
- Event key
- 0
- Event type
- 3
- Date of event
- 2026-09-10
- Date received
- 2026-09-30
- Adverse event
- 0
- Product problem
- 1
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 1
- Initial report to FDA
- 0
- Event location
- 0
Manufacturer Contact#
- Contact
- Mark Mischke
- Address
- 4100 Hamline Avenue North Saint Paul MN 55112 US
- Report source
- M
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 418165 | ENDOTAK RELIANCE | Implantable Lead | BOSTON SCIENTIFIC CORPORATION | LWS | 0148 | 0148 | N | |||||
| 510574 | ENDOTAK RELIANCE | Implantable Lead | BOSTON SCIENTIFIC CORPORATION | LWS | 0148 | 0148 | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2026-09-30 | 0 |
Event Narratives#
No narrative records found.