FDA Adverse Event
Injury
Summary report: N
VICTORY XL DR
MDR report key: 1073266
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02065
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- April 28, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DXY
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SYMPTOMATIC PATIENT PRESENTED WITH THE DEVICE IN BACKUP VVI MODE. SEVERAL DOWLOAD ATTEMPTS WERE MADE, HOWEVER THE DEVICE CONTINUED TO GO BACK INTO BVVI MODE. THE DEVICE WAS REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VICTORY XL DR | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 5816 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |