FDA Adverse Event
Injury
Summary report: N
ACCENT DR RF
MDR report key: 2905163
·
Received January 9, 2013
Report
- Report Number
- 2017865-2013-00828
- Event Type
- Injury
- Date Received
- January 9, 2013
- Date of Event
- October 6, 2012
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DXY
- PMA / PMN Number
- NA
- Removal / Correction Number
- Z0429
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED. ANALYSIS WAS NORMAL.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY EXPERIENCING SYNCOPAL EPISODES. THE PULSE GENERATOR EXHIBITED NOISE. ON (B)(6), DURING A FOLLOW UP VENTRICULAR NOISE WAS NOTED. THE PT WAS PROVIDED WITH ZIO PATCH TO CORRELATE NOISE W/SYMPTOMS. ON (B)(6), THE DEVICE WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 12014 | ACCENT DR RF | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | PM2210 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Required Intervention | (B)(4) |