FDA Adverse Event
Malfunction
Summary report: N
VICTORY XL DR
MDR report key: 3920392
·
Received July 8, 2014
Report
- Report Number
- 2017865-2014-14017
- Event Type
- Malfunction
- Date Received
- July 8, 2014
- Date of Event
- May 6, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- LWP
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS UNDERGOING RADIATION THERAPY. PATIENT PRESENTED IN CLINIC AFTER THE TENTH TREATMENT EXPERIENCING TWITCHING IN THE PACEMAKER POCKET. UPON INTERROGATION, THE PULSE GENERATOR EXHIBITED BACKUP VVI MODE. AFTER A SOFTWARE DOWNLOAD, NORMAL DEVICE FUNCTION RESUMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 397602 | VICTORY XL DR | IMPLANTABLE PACEMAKER PULSE GENERATOR | LWP | ST. JUDE MEDICAL, INC., CRMD | 5816 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR |