FDA Adverse Event
Injury
Summary report: N
RIATA ST OPTIM ACTIVE-FIXATION LEAD
MDR report key: 1073540
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02434
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- April 22, 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
ANALYSIS FOUND THE LEAD TO EXHIBIT NORMAL ELECTRICAL CHARACTERISTICS AND IMPEDANCE. FURTHER ANALYSIS FOUND THE HELIX COULD NOT BE EXTENDED DUE TO DRIED BODY FLUID IN THE LEAD DISTAL COIL AND HELIX. THE LEAD WAS CUT AT 52 CM FROM THE CONNECTOR PIN. THE HELIX COULD BE FULLY EXTENDED AND RETRACTED BY APPLYING TORQUE DIRECTLY TO THE DISTAL COIL OF THE REMAINING PORTION. NO ANOMALIES WERE NOTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT LOW R-WAVES AND HIGH IMPEDANCE WAS OBSERVED. A REPOSITION WAS UNSUCCESSFUL AND THE LEAD WAS REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ST OPTIM ACTIVE-FIXATION LEAD | DEFIBRILLATION LEAD | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7022/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |