FDA Adverse Event
Injury
Summary report: N
ATLAS II PLUS DR
MDR report key: 1223466
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03646
- Event Type
- Injury
- Date Received
- November 10, 2008
- Date of Event
- August 29, 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 Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE FIELD EXPERIENCE OF EXTENDED CHARGE TIME WAS VERIFIED IN THE LABORATORY. THE CAUSE OF THE EXTENDED CHARGE TIME WAS A DAMAGED HIGH VOLTAGE CAPACITOR. THE DEVICE PASSED PARTIAL LOW VOLTAGE TESTING.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE BATTERY DEPLETED PREMATURELY DUE TO EXTENDED CHARGE TIME. 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 |