FDA Adverse Event
Malfunction
Summary report: N
ATLAS II VR
MDR report key: 1073150
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02507
- Event Type
- Malfunction
- Date Received
- July 11, 2008
- Date of Event
- April 30, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- FL
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS IN BACK-UP VVI RESET MODE. ATTEMPTS TO RECOVER THE DEVICE WERE UNSUCCESSFUL. THE PATIENT HAD UNDERGONE A SERIES OF RADIATION TREATMENTS. THE PHYSICIAN BELIEVED THAT A SURGERY TO REPLACE THE DEVICE WOULD BE TOO RISKY AT THIS TIME.
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 |