FDA Adverse Event
Malfunction
Summary report: N
RIATA ST OPTIM ACTIVE FIXATION
MDR report key: 1073610
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02494
- Event Type
- Malfunction
- Date Received
- July 11, 2008
- Date of Event
- May 5, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- KY
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT AN ASYMPTOMATIC PATIENT PRESENTED TO THE CLINIC WITH POST-SENSED T-WAVE OVERSENSING ON THE VENTRICULAR LEAD. THE PATIENT RECEIVED INAPPROPRIATE THERAPY AS A RESULT. THE LEAD REMAINS IMPLANTED.
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 |