FDA Adverse Event
Injury
Summary report: N
ATLAS II PLUS DR
MDR report key: 1223427
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03656
- Event Type
- Injury
- Date Received
- November 10, 2008
- Date of Event
- September 15, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMAP910023
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE REPORTED FIELD EXPERIENCE OF HWVVI MODE WAS CONFIRMED IN THE LABORATORY. UPON INTERROGATION, THE DEVICE WAS FOUND TO BE IN HWVVI MODE. ANALYSIS OF THE RAM MAP REVEALED THAT THE DEVICE HAD GONE INTO HWVVI MODE IN 2008, AFTER DETECTING SEVERAL PARITY ERRORS. AN X-RAY INSPECTION REVEALED NO ANOMALIES. THE CAUSE OF THE PARITY ERRORS COULD NOT BE CONCLUSIVELY DETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE HAD GONE INTO BVVI MODE. THE DEVICE WAS REPLACED.
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 | Required Intervention |