FDA Adverse Event
Malfunction
Summary report: N
ATLAS II PLUS HF CRT-D
MDR report key: 1895873
·
Received November 10, 2010
Report
- Report Number
- 2017865-2010-04796
- Event Type
- Malfunction
- Date Received
- November 10, 2010
- Date of Event
- August 20, 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 Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. (B)(4). FAILURE (EVENT) OBSERVED DURING ANALYSIS UPON INTERROGATION, NO COMMUNICATION COULD BE ESTABLISHED WITH THE DEVICE DUE TO A DEPLETED BATTERY. THE DEVICE WAS ANALYZED WITH A NEW BATTERY AND FOUND TO BE NORMAL. THE BATTERY WAS SENT OUT TO THE VENDOR FOR FURTHER EVALUATION, AND NO ANOMALY WAS DETECTED. THE CAUSE FOR THE PREMATURE BATTERY DEPLETION COULD NOT BE DETERMINED.
Description of Event or Problem · 1
THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ATLAS II PLUS HF CRT-D | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | V-366 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |