FDA Adverse Event
Malfunction
Summary report: N
ATLAS PLUS VR
MDR report key: 2950151
·
Received February 8, 2013
Report
- Report Number
- 2938836-2013-00072
- Event Type
- Malfunction
- Date Received
- February 8, 2013
- Date of Event
- December 20, 2012
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE HAD GONE INTO HARDWARE BACKUP MODE WITH NO DEFIBRILLATION AVAILABLE. THE DEVICE WAS NOTED TO BE AT ERI. THE DEVICE WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 54501 | ATLAS PLUS VR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | V-193 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | 1580/65, (B)(4) |