FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM PASSIVE FIXATION, DF4 CONNECTOR
MDR report key: 3080144
·
Received April 26, 2013
Report
- Report Number
- 2938836-2013-00992
- Event Type
- Injury
- Date Received
- April 26, 2013
- Date of Event
- February 18, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVY
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- 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 DURING NORMAL FOLLOW UP, SENSING, PACING THRESHOLD AND PACING IMPEDANCE WERE ALL OUT OF RANGE. DURING THRESHOLD TESTING, PATIENT FELT PHRENIC NERVE STIMULATION. ON (B)(6) 2013, AN XRAY WAS PERFORMED AND SHOWED THE RV LEAD HAD MOVED FROM ITS ORIGINAL POSITION. AN ECHO SHOWED A MINIMAL EFFUSION WHICH WAS CLASSIFIED AS NON SIGNIFICANT. ELECTRICAL MEASUREMENTS WERE STABLE. PATIENT CONDITION AFTER THE EVENT WAS GOOD. LEAD REMAINS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 180802 | DURATA STS OPTIM PASSIVE FIXATION, DF4 CONNECTOR | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7172Q/58 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR |