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 9890588
- MDR report key
- 9890588
- Report number
- 2017865-2020-04273
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-03-13
- Date received
- 2020-03-27
- 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 | VICTORY XL DR | IMPLANTABLE PACEMAKER PULSE GENERATOR | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) | DXY | 5816 | 5816 | 2908839 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-27 | 0 | 1. R |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR A FOLLOW-UP. UPON REVIEW, IT WAS DISCOVERED THAT THE PACEMAKER EXHIBITED INCORRECT MEASUREMENTS FOR FALSE ELECTIVE REPLACEMENT INDICATOR. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.