FDA Adverse Event
Injury
Summary report: N
FORTIFY DR
MDR report key: 3890399
·
Received January 13, 2014
Report
- Report Number
- 2938836-2014-03579
- Event Type
- Injury
- Date Received
- January 13, 2014
- Date of Event
- July 21, 2011
- Manufacturer
- ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- 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 A PATIENT PRESENTED IN THE EMERGENCY ROOM WITH POST-SENSED T-WAVE OVERSENSING AND INAPPROPRIATE ATP. IT WAS RECOMMENDED THAT THE VENTRICULAR SENSITIVITY BE DECREASED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 30990 | FORTIFY DR | LWS | ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D | CD2231-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR |