FDA Adverse Event
Injury
Summary report: N
ATLAS II VR
MDR report key: 1223209
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03713
- Event Type
- Injury
- Date Received
- November 10, 2008
- Date of Event
- July 16, 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
- TN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS FOUND THAT THE DEVICE WAS IN HARDWARE VVI MODE AND THAT A MICRO RESET HAD OCCURRED. THE DEVICE FUNCTIONED NORMALLY WITH A REPLACEMENT BATTERY AND NO ANOMALY WAS DETECTED. THE CAUSE OF THE MICRO RESET COULD NOT BE CONCLUSIVELY DETERMINED. THE DEVICE MEMORY MAP COULD NOT BE RETRIEVED AND LONGEVITY PERFORMANCE COULD NOT BE VERIFIED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE BATTERY WAS DEPLETED, AND THE PATIENT RECEIVED MULTIPLE SHOCKS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ATLAS II VR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | V-168 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |