MAUDE MDR 50941438
- MDR report key
- 50941438
- Report number
- 2017865-2026-20334
- Event key
- 0
- Event type
- 3
- Date of event
- 2026-09-10
- Date received
- 2026-09-30
- Adverse event
- 1
- Product problem
- 1
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 1
- Initial report to FDA
- 0
- Event location
- 0
Devices#
Seq, Brand, Generic table| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|
| 319550 | TENDRIL SDX LEAD | Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes | Abbott Medical (CRM-Sylmar) | NVN | 1488TC/46 | | 0002679707 | | | | N | N |
| 418189 | TENDRIL SDX LEAD | Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes | Abbott Medical (CRM-Sylmar) | NVN | 1488TC/46 | | 0002679707 | | | | N | N |
Patients#
Sequence, Received, Treatment table| Sequence | Received | Treatment | Outcome |
|---|
| 1 | 2026-09-30 | 0 | R |
Event Narratives#
No narrative records found.