FDA Adverse Event
Malfunction
Summary report: N
ATLAS II PLUS HF CRT-D
MDR report key: 3220387
·
Received July 11, 2013
Report
- Report Number
- 2938836-2013-04698
- Event Type
- Malfunction
- Date Received
- July 11, 2013
- Date of Event
- April 24, 2013
- 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
- OH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED THE REPORTED FIELD EVENT OF AN IMPEDANCE MEASUREMENT ANOMALY WAS CONFIRMED VIA REVIEW OF IMPEDANCE MEASUREMENT TREND DATA STORED ON THE DEVICE. THE DEVICE WAS TESTED ON THE BENCH AND WAS FOUND TO BE NORMAL. THE CAUSE OF THE FIELD EVENT COULD NOT BE DETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS BEING CHANGED OUT FOR NORMAL ERI. A DIFFERENCE IN PACING LEAD IMPEDANCE MEASUREMENTS WERE OBSERVED BETWEEN THE CHRONIC DEVICE AND THE SYSTEM ANALYZER AND NEWLY IMPLANTED DEVICE. THE CHRONIC DEVICE PRODUCED LOWER IMPEDANCE MEASUREMENTS. THE NEW DEVICE REMAINS IMPLANTED AND THE OLD DEVICE WAS RETURNED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 320559 | 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 | 77 YR | 1582/65, RJ14776 |