FDA Adverse Event
Injury
Summary report: N
RIATA ST OPTIM ACTIVE FIXATION LEAD
MDR report key: 1896081
·
Received November 10, 2010
Report
- Report Number
- 2017865-2010-04441
- Event Type
- Injury
- Date Received
- November 10, 2010
- Date of Event
- August 31, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVY
- 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.
Additional Manufacturer Narrative · 1
EXTERNAL INSULATION ABRASION WAS FOUND PROXIMAL TO THE RV COIL. THE EFTE COATING WAS INTACT AT THE SAME LOCATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC DUE TO A DEVICE ALERT. HIGH IMPEDANCE WAS OBSERVED. THE SYSTEM WAS EXPLANTED AND REPLACED DUE TO THE PATIENT'S CONDITION AND NOT DUE TO THE IMPEDANCE ANOMALY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ST OPTIM ACTIVE FIXATION LEAD | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7021/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |