FDA Adverse Event
Injury
Summary report: N
RIATA ST OPTIM ACTIVE FIXATION
MDR report key: 1073593
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02477
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- April 28, 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 ANALYSIS FOUND THAT THE HELIX EXTENSION WAS WITHIN SPECIFICATION. THE HELIX WAS CLOGGED WITH DRIED BODY FLUID, PREVENTING IT FROM EXTENDING AND RESULTING IN THE DISTAL COIL BEING OVERTORQUED. THE DAMAGE IS CONSISTENT WITH THAT OCCURRING DURING THE SURGICAL PROCEDURE.
Description of Event or Problem · 1
IT WAS REPORTED THAT HIGH LEAD IMPEDANCE WAS OBSERVED. LEAD DISLODGMENT WAS SUSPECTED. DURING THE LEAD REVISION, A HELIX ANOMALY WAS OBSERVED. 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 | 7020/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |