FDA Adverse Event
Injury
Summary report: N
ATLAS PLUS VR
MDR report key: 3090106
·
Received May 2, 2013
Report
- Report Number
- 2938836-2013-01271
- Event Type
- Injury
- Date Received
- May 2, 2013
- Date of Event
- February 7, 2013
- 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
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Additional Manufacturer Narrative · 1
THE DEVICE WAS TESTED ON THE BENCH AND NO ANOMALIES WERE OBSERVED. DEVICE FUNCTIONALITY WAS NORMAL.
Additional Manufacturer Narrative · 1
DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS FOUND IN BACKUP VVI MODE AND COULD NOT BE INTERROGATED. IT WAS NOTED THAT THE DEVICE WAS AT EOL. THE DEVICE WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 191149 | ATLAS PLUS VR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | V-193 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |