FDA Adverse Event
Injury
Summary report: N
RIATA ST OPTIM ACTIVE FIXATION
MDR report key: 1073042
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02292
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- April 2, 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
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED THE LEAD EXHIBITED NORMAL ELECTRICAL CHARACTERISTICS DRIED BODY FLUID/TISSUE INSIDE THE HEADER AND INNER INSULATION PREVENTED HELIX EXTENSION. TOO MANY REVOLUTIONS WHEN ATTEMPTING TO EXTEND.RETRACT THE HELIX CAUSED OVER-TORQUE OF THE INNER COIL. AFTER CLEANING AND SECTIONING, NORMAL HELIX MECHANISM WAS FOUND.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD WAS REMOVED DUE TO DISLODGEMENT. DURING REPLACEMENT, THE HELIX WOULD NOT TURN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ST OPTIM ACTIVE FIXATION | DEFIBRILLATION LEAD | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7020/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |