FDA Adverse Event
Injury
Summary report: N
ATLAS II VR
MDR report key: 1073602
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02486
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- May 2, 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
- NC
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Additional Manufacturer Narrative · 1
THE DEVICE WAS FOUND WITH NO TELEMETRY WHEN IT WAS RECEIVED. IT WAS DETERMINED THAT THE LOSS OF TELEMETRY WAS CAUSED BY A LOW BATTERY VOLTAGE. THE DEVICE CURRENT WAS MEASURED AND IT WAS FOUND TO BE NORMAL. THE DEVICE WAS TESTED IN THE AUTOMATED TEST ELECTRICAL SYSTEM AND NO ANOMALY WAS DETECTED . THE DEVICE MET ALL SPECIFICATIONS. NO ANOMALY WAS IDENTIFIED THAT WOULD EXPLAIN THE PREMATURE DEPLETION OF THE BATTERY.
Description of Event or Problem · 1
THE DEVICE WAS EXPLANTED DUE TO EARLY 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 |