FDA Adverse Event
Injury
Summary report: N
ACCENT DR RF
MDR report key: 1896206
·
Received November 10, 2010
Report
- Report Number
- 2017865-2010-05381
- Event Type
- Injury
- Date Received
- November 10, 2010
- Date of Event
- August 4, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DXY
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- 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. REVIEW OF QUALITY RECORDS.
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT PRESENTED TO HOSPITAL WITH THE PACEMAKER SITE AREA RED AND WARM TO THE TOUCH. THE PATIENT WAS ADMITTED FOR ANTIBIOTIC THERAPY AND INFECTIOUS DISEASE CONSULTATION. THE PULSE GENERATOR WAS EXPLANTED AND PLACED IN ANTIBIOTIC SOLUTION. THE POCKET WAS CLEANED AND THE DEVICE WAS REPLACED IN THE PECTORALIS.
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 | 60 YR | Required Intervention | OSC-ZY44, (B)(4), BIO-338023, (B)(4) |