FDA Adverse Event
Injury
Summary report: N
ATLAS II VR
MDR report key: 2242401
·
Received September 10, 2011
Report
- Report Number
- 2017865-2011-06615
- Event Type
- Injury
- Date Received
- September 10, 2011
- Date of Event
- June 20, 2011
- 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 REPORTED PREMATURE BATTERY DEPLETION WAS NOT CONFIRMED IN THE LABORATORY. BASED ON THE DEVICE'S PARAMETERS, IT IS WITHIN EXPECTED LONGEVITY PERFORMANCE. THE DEVICE WAS TESTED ON THE BENCH AND ON OUR AUTOMATED TESTING EQUIPMENT AND WAS FOUND TO BE NORMAL. THE DEVICE MET ALL SPECIFICATIONS.
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. OTHER TEXT: DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Description of Event or Problem · 1
IT WAS REPORTED THAT PREMATURE ERI WAS SUSPECTED. DEVICE WAS EXPLANTED AND REPLACED.
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 | 49 YR | Required Intervention |