D
Patient 1
REPORTEDLY, THE STATUS LED OF THE SUBJECT HOME MONITOR REMAINED RED DURING THE PAIRING PROCESS AND THE PROCESS COULD NOT BE COMPLETED.
MAUDE MDR 8450945
- MDR report key
- 8450945
- Report number
- 1000165971-2019-00161
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-02-06
- Date received
- 2019-03-26
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- ELODIE VINCENT
- Address
- PARC D'AFFAIRES NOVEOS 4 AVENUE R . CLAMART 92140 FR
- Phone
- 14-14-0146
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | SMARTVIEW | UNKNOWN | SORIN GROUP ITALIA S.R.L. - CRM FACILITY | OSR | SMARTVIEW PSTN | SMARTVIEW PSTN | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-03-26 | 0 |