N
Patient 1
THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.
MAUDE MDR 9908430
- MDR report key
- 9908430
- Report number
- 2017865-2020-04495
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-03-27
- Date received
- 2020-03-31
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- ELIZABETH BOLTZ
- Address
- 15900 VALLEY VIEW COURT SYLMAR CA 91342 US
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ASSURITY RF DR | IMPLANTABLE PACEMAKER PULSE GENERATOR | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) | NVZ | PM2240 | PM2240 | A000044298 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-31 | 0 | 1. R |
Event Narratives#
D
Patient 1
RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2020-04496, 2017865-2020-04497. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION. THE SOURCE OF INFECTION WAS UNKNOWN. THE PACEMAKER SYSTEM WAS EXPLANTED ON (B)(6) 2020. THE PATIENT WAS STABLE.