FDA Adverse Event
Injury
Summary report: N
VICTORY XL DR
MDR report key: 2240041
·
Received September 8, 2011
Report
- Report Number
- 2017865-2011-05917
- Event Type
- Injury
- Date Received
- September 8, 2011
- Date of Event
- August 1, 2011
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWP
- PMA / PMN Number
- P880086
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Additional Manufacturer Narrative · 1
FINAL ANALYSIS FOUND THAT THE PULSE GENERATOR WAS IN BACK-UP MODE. THE REPORTED OUTPUT ANOMALY WAS REPRODUCED DURING TEMPERATURE CYCLE TESTING. AFTER FURTHER TESTING NO OUTPUT ANOMALIES WERE OBSERVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT ON 7/23 THE PATIENT EXPERIENCED A SYNCOPE EPISODE AND PRESENTED TO THE EMERGENCY ROOM. THE PULSE GENERATOR WAS INTERROGATED AND STABLE IMPEDANCE VALUES WERE NOTED. THE PATIENT UNDERWENT AN ICD UPGRADE ON 7/25 AND THE DEVICE EXHIBITED AN OUTPUT ANOMALY. THE DEVICE WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VICTORY XL DR | IMPLANTABLE PACEMAKER PULSE GENERATOR | LWP | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 5816 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Required Intervention |