FDA Adverse Event
Malfunction
Summary report: N
ACCENT DR RF
MDR report key: 2240340
·
Received September 9, 2011
Report
- Report Number
- 2017865-2011-05975
- Event Type
- Malfunction
- Date Received
- September 9, 2011
- Date of Event
- July 19, 2011
- 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
- MO
- 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
IT WAS REPORTED THAT THE PULSE GENERATOR EXHIBITED VENTRICULAR NOISE REVERSION EPISODES AND VENTRICULAR PAUSES BETWEEN TWO AND THREE SECONDS. THE VENTRICULAR SENSITIVITY WAS REPROGRAMMED TO 2.0 MV. THE PATIENT WAS PACEMAKER DEPENDENT AND WILL BE MONITORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCENT DR RF | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | PM2210 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR |