FDA Adverse Event
Injury
Summary report: N
EPIC VR
MDR report key: 2242966
·
Received September 11, 2011
Report
- Report Number
- 2017865-2011-06633
- Event Type
- Injury
- Date Received
- September 11, 2011
- Date of Event
- June 30, 2011
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- 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 THE REPORTED DEVICE RESET WAS CONFIRMED. HIGH CURRENT WAS FOUND IN THE HYBRID DUE TO AN ANOMALOUS IC COMPONENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A FOLLOW-UP, THE DEVICE WAS FOUND TO BE IN BACKUP VVI MODE. THE DEVICE WAS EXPLANTED AFTER EACH ATTEMPT TO REPROGRAM THE DEVICE, IT REVERTED TO RESET MODE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EPIC VR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | V-197 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |