FDA Adverse Event
Malfunction
Summary report: N
VICTORY XL DR
MDR report key: 2014234
·
Received March 10, 2011
Report
- Report Number
- 2017865-2011-01776
- Event Type
- Malfunction
- Date Received
- March 10, 2011
- Date of Event
- January 6, 2011
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DXY
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. (B)(4) FACILITY.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD IMPEDANCE TREND WAS USUALLY AROUND 600 OHMS. HOWEVER, TRENDING REVEALED THAT TWICE, THE IMPEDANCE ROSE TO 1200 OHMS THEN RETURNED TO 600 OHMS THE FOLLOWING DAY.
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 | 5810 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |