FDA Adverse Event
Injury
Summary report: N
RIATA ST ACTIVE FIXATION LEAD
MDR report key: 1073127
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02369
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- April 1, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE REASON FOR RETURN WAS NOT CONFIRMED. THE LEAD EXHIBITED NORMAL ELECTRICAL CHARACTERISTICS. THE HELIX COULD NOT BE EXTENDED AS THE HELIX WAS CLOGGED WITH DRIED BODY FLUID/ TISSUE. BODY FLUIDS INSIDE THE ENTIRE DISTAL INSULATION COIL PREVENTED PROPER DISTAL COIL ROTATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE R-WAVES DECREASED AND THRESHOLD INCREASED. THE LEAD WAS REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ST ACTIVE FIXATION LEAD | DEFIBRILLATION LEAD | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7000/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |