FDA Adverse Event
Malfunction
Summary report: N
VICTORY XL DR
MDR report key: 6088275
·
Received November 8, 2016
Report
- Report Number
- 2017865-2016-07062
- Event Type
- Malfunction
- Date Received
- November 8, 2016
- Date of Event
- September 19, 2016
- Report Date
- September 19, 2016
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
- Product Code
- LWP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT WHEN AN ASYMPTOMATIC PATIENT COMPLETED THEIR LAST ROUND OF RADIATION TREATMENT, THE DEVICE WAS FOUND TO BE IN BACKUP VVI MODE. A FIRMWARE DOWNLOAD WAS PERFORMED SUCCESSFULLY TO RESTORE THE DEVICE. THE PATIENT WILL CONTINUE TO BE MONITORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 736733 | VICTORY XL DR | IMPLANTABLE PACEMAKER PULSE GENERATOR | LWP | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) | 5810 | 2792287 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR |