FDA Adverse Event
Malfunction
Summary report: N
ISOFLEX S
MDR report key: 952159
·
Received November 1, 2007
Report
- Report Number
- 952159
- Event Type
- Malfunction
- Date Received
- November 1, 2007
- Date of Event
- October 26, 2007
- Report Date
- November 1, 2007
- Manufacturer
- ST. JUDE MEICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DTB
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- ND, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ENDOCARDIAL STEROID-ELUTING TINED "J" LEAD 1642T, OUTSIDE BOX INDICATES, USE BEFORE: 2010/07/31. INSIDE PACKAGING OF PRODUCT WITH SAME SERIAL NUMBER INDICATES USE BEFORE: 2007/07/31. MANUFACTURE DATE ON BOTH 2007/07/01. ST JUDE MEDICAL REPRESENTATIVE CONTACTED WITH REGARDS TO THE DISCREPANCY, THEY VERIFIED THAT THE USE BEFORE: 2010/07/31, IS INDEED THE CORRECT DATE. PROCEDURE CONTINUED, LEAD WAS PLACED, NO COMPLICATIONS. FULL DISCLOSURE MADE TO PATIENT, WHO INDICATED FULL UNDERSTANDING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ISOFLEX S | ENDOCARDIAL STEROID-ELUTING TINED "J" | DTB | ST. JUDE MEICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1642T |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR |