FDA Adverse Event
Malfunction
Summary report: N
ATLAS PLUS HF CRT-D
MDR report key: 1954739
·
Received January 10, 2011
Report
- Report Number
- 2017865-2011-00587
- Event Type
- Malfunction
- Date Received
- January 10, 2011
- Date of Event
- November 29, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NIK
- PMA / PMN Number
- P030054
- 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
THE DEVICE WAS FOUND IN SOFTWARE RESET. (THE DEVICE WILL STILL PACE AND PROVIDE THERAPY WHEN IN THIS RESET MODE.) IT WAS REPORTED THAT THE PATIENT HAS A BRAIN HEMORRHAGE. THE PHYSICIAN DOES NOT CONSIDER THE DEVICE RESTORATION A PRIORITY DUE TO THE PATIENT'S UNSTABLE CONDITION. ONCE THE PATIENT IS STABILIZED, THE DEVICE WILL BE EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ATLAS PLUS HF CRT-D | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | V-340 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR |