FDA Adverse Event
Injury
Summary report: N
ACCENT DR RF
MDR report key: 2240531
·
Received September 9, 2011
Report
- Report Number
- 2017865-2011-05967
- Event Type
- Injury
- Date Received
- September 9, 2011
- Date of Event
- July 15, 2011
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DXY
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT ONE DAY POST IMPLANT, THE ATRIAL LEAD IMPEDANCE MEASURED GREATER THAN 3000 OHMS. THE POCKET WAS RE-OPENED AND AFTER PROPERLY TIGHTENING THE PULSE GENERATOR SETSCREW, LEAD IMPEDANCE MEASUREMENTS WERE APPROPRIATE.
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 | 81 YR | Required Intervention |