MAUDE MDR 9391602
- MDR report key
- 9391602
- Report number
- 2649622-2019-22246
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-11-05
- Date received
- 2019-11-29
- Adverse event
- 1
- Product problem
- 1
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 0
- Initial report to FDA
- 0
- Event location
- 3
Devices#
Seq, Brand, Generic table| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|
| 1 | CAPSUREFIX NOVUS LEAD MRI SURESCAN | ELECTRODE, PACEMAKER, PERMANENT | MPRI | DTB | 5076-52 | 5076-52 | | | | | *
| N |
| 1017864 | CAPSUREFIX NOVUS LEAD MRI SURESCAN | ELECTRODE, PACEMAKER, PERMANENT | MPRI | DTB | 5076-52 | 5076-52 | | | | | | R |
Patients#
Sequence, Received, Treatment table| Sequence | Received | Treatment | Outcome |
|---|
| 1 | 2019-11-29 | 0 | 1. H; 2. R
|
Event Narratives#
No narrative records found.