FDA Adverse Event
Injury
Summary report: N
ATLAS II PLUS DR
MDR report key: 2242415
·
Received September 10, 2011
Report
- Report Number
- 2017865-2011-06644
- Event Type
- Injury
- Date Received
- September 10, 2011
- Date of Event
- June 9, 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 EVENT WAS CONFIRMED. THE RESET WAS CAUSED BY AN EXCESSIVELY HIGH RATE OF PARITY MICRO-RESETS.
Description of Event or Problem · 1
THE DEVICE WAS EXPLANTED DUE TO BACKUP VVI RESET MODE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ATLAS II PLUS DR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | V-268 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention |