FDA Adverse Event
Malfunction
Summary report: N
ACCENT DR RF
MDR report key: 2983798
·
Received February 28, 2013
Report
- Report Number
- 2017865-2013-01636
- Event Type
- Malfunction
- Date Received
- February 28, 2013
- Date of Event
- December 18, 2012
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DXY
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT COMPLAINED OF PALPITATIONS AND WEAKNESS. EGMS REVEALED TACHYARRHYTHMIA, ATRIAL FLUTTER AND ATRIAL FIBRILLATION. THE PULSE GENERATOR EXHIBITED ATRIAL PACE ON PVC ALGORITHM. THE PVARP WAS SHORTENED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 87763 | ACCENT DR RF | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | PM2210 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR |