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 9904346
- MDR report key
- 9904346
- Report number
- 2017865-2020-04460
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-03-22
- 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 | ELLIPSE DR ICD | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) | NVZ | CD2411-36C | CD2411-36C | A000026528 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-31 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT THE ASYMPTOMATIC PATIENT PRESENTED FOR IN-CLINIC FOLLOW UP WITH THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR IN BACKUP OPERATION. A FIRMWARE DOWNLOAD WAS SUCCESSFULLY PERFORMED, AND DEVICE PARAMETERS WERE RESTORED.