FDA Adverse Event
Injury
Summary report: N
PROMOTE RF
MDR report key: 1050882
·
Received May 27, 2008
Report
- Report Number
- 2017865-2008-01824
- Event Type
- Injury
- Date Received
- May 27, 2008
- Date of Event
- March 22, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL
- 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 HIGH IMPEDANCE WAS OBSERVED TWO DAYS POST IMPLANT. THE POCKET WAS OPENED UP AND THE LEAD EASILY CAME LOOSE FROM THE HEADER. THE LEAD WAS REINSERTED INTO THE HEADER, AND IMPEDANCE MEASUREMENTS WERE ACCEPTABLE. THE SYSTEM REMAINS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROMOTE RF | NO BNCN FOUND FOR THIS DEVICE | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 3207-36 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |