FDA Adverse Event
Injury
Summary report: N
RIATA ST OPTIM ACTIVE FIXATION
MDR report key: 1223790
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03489
- Event Type
- Injury
- Date Received
- November 10, 2008
- Date of Event
- September 11, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMAP95022
- 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 FIELD EXPERIENCE WAS CONFIRMED. X-RAY ANALYSIS FOUND THE DISTAL COIL FRACTURED NEAR THE RING ELECTRODE. S.E.M. PHOTOGRA PHS REVEALED ALL THE WIRES OF THE DISTAL COIL WERE FRACTURED. THE CAUSE OF THE FRACTURE COULD NOT BE DETERMINED.
Description of Event or Problem · 1
PATIENT PRESENTED TO THE CLINIC FOR FOLLOW UP. LEAD WAS FOUND TO HAVE LOSS OF CAPTURE AND NO SENSING. AS SUCH, THE LEAD WAS EXPLANTED.
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 | 7022/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |