FDA Adverse Event
Injury
Summary report: N
ATLAS II VR
MDR report key: 1071890
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02312
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- April 29, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED THE FIELD EXPERIENCE OF PREMATURE BATTERY DEPLETION WAS VERIFIED IN THE LABORATORY. THE BATTERY DEPLETION WAS CAUSED BY AN INTERNAL SHORT WITHIN THE BATTERY.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS REMOVED DUE TO EXCESSIVE BATTERY DEPLETION.
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 |