FDA Adverse Event
Injury
Summary report: N
ATLAS II PLUS DR
MDR report key: 1955248
·
Received January 10, 2011
Report
- Report Number
- 2017865-2011-00585
- Event Type
- Injury
- Date Received
- January 10, 2011
- Date of Event
- November 3, 2010
- 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
THE PREMATURE BATTERY DEPLETION WAS CONFIRMED IN THE LABORATORY. A LONGEVITY CALCULATION FOUND THAT THE DEVICE WAS NOT WITHIN THE EXPECTED LONGEVITY PERFORMANCE. DEVICE FUNCTIONALITY WAS NORMAL THROUGHOUT TESTING. THE BATTERY WAS SENT TO THE VENDOR FOR FURTHER ANALYSIS. AN INTERNAL ANOMALY WAS FOUND TO BE THE CAUSE FOR THE PREMATURE BATTERY DEPLETION.
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE EXHIBITED PREMATURE BATTERY DEPLETION.
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 | 19 YR | Required Intervention |