FDA Adverse Event
Injury
Summary report: N
RIATA ST OPTIM ACTIVE FIXATION
MDR report key: 1223783
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03492
- Event Type
- Injury
- Date Received
- November 10, 2008
- Date of Event
- August 15, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- 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 DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE. THE LEAD TIP STIFFNESS WAS WITHIN SPECIFICATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT ABOUT ONE MONTH POST IMPLANT, PERFORATION OR IMFLAMMATION OF THE APEX WAS SUSPECTED. THERE WAS NO PERICARDIAL EFFUSION. A FEW WEEKS LATER, THERE WAS AN INCREASE IN PACING THRESHOLDS AND A DECREASE IN VENTRICULAR SENSING. ATTEMPTS TO REPOSITION THE LEAD WERE UNSUCCESSFUL DUE TO A BROKEN HELIX.
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 |