FDA Adverse Event
Malfunction
Summary report: N
ATLAS + HF CRT-D
MDR report key: 1050696
·
Received May 27, 2008
Report
- Report Number
- 2017865-2008-01653
- Event Type
- Malfunction
- Date Received
- May 27, 2008
- Date of Event
- March 3, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NIK
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
UPON INTERROGATION, THE DEVICE WAS FOUND TO BE IN A HARDWARE RESET MODE. IT WAS NOTED THAT THE PATIENT MAY HAVE RECEIVED EXTERNAL DEFIBRILLATION, AND ALSO, THE PATIENT MAY HAVE BEEN LOST TO FOLLOW-UP. IT WAS RECOMMENDED TO EXPLANT THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ATLAS + HF CRT-D | NO BNCN FOUND FOR THIS DEVICE | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | V-343 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |