FDA Adverse Event
Malfunction
Summary report: N
PROMOTE RF
MDR report key: 3880447
·
Received January 13, 2014
Report
- Report Number
- 2938836-2014-03503
- Event Type
- Malfunction
- Date Received
- January 13, 2014
- Date of Event
- February 1, 2011
- Manufacturer
- ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D
- Product Code
- NIK
- PMA / PMN Number
- P910023
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD.
Description of Event or Problem · 1
IT WAS REPORTED THAT AT/AF BURDEN PERCENTAGE WAS INCONSISTENT WITH ALL OTHER DIAGNOSTIC DATA. SESSION RECORDS WERE SUBMITTED FOR REVIEW. DEVICE REMAINED IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 24772 | PROMOTE RF | NIK | ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D | 3207-36 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR |