FDA Adverse Event
Malfunction
Summary report: N
FORTIFY ST DR, DF4 CONNECTOR
MDR report key: 3090148
·
Received May 2, 2013
Report
- Report Number
- 2938836-2013-01190
- Event Type
- Malfunction
- Date Received
- May 2, 2013
- Date of Event
- February 7, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT NOISE WAS OBSERVED ON ATRIAL LEAD. THE DEVICE AUTO SENSITIVITY SETTING WAS CHANGED.NEW INFORMATION RECEIVED NOTES THAT NOISE WAS OBSERVED AT VARIOUS TIMES. THE NOISE WAS NOT REPRODUCIBLE.
Description of Event or Problem · 1
NEW INFORMATION RECEIVED NOTES THAT DURING A RECENT PATIENT FOLLOWUP, NOISE ON THE ATRIAL CHANNEL WAS REPRODUCED IN CLINIC WITH ISOMETRIC TESTING. THE ATRIAL CHANNEL WAS PROGRAMMED OFF.
Description of Event or Problem · 1
IT WAS REPORTED THAT NOISE WAS OBSERVED ON THE ATRIAL LEAD. THE DEVICE AUTO SENSITIVITY SETTING WAS CHANGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 191820 | FORTIFY ST DR, DF4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD2235-40Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | 2088TC/46 (B)(4) |