FDA Adverse Event
Injury
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 2890140
·
Received December 28, 2012
Report
- Report Number
- 2017865-2012-10670
- Event Type
- Injury
- Date Received
- December 28, 2012
- Date of Event
- November 20, 2012
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- Z0457
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Additional Manufacturer Narrative · 1
A PARTIAL LEAD WITH THE LEAD TIP MEASURING 52.0CM WAS RETURNED FOR ANALYSIS. EXTERNALIZED CONDUCTORS DUE TO INTERNAL INSULATION ABRASION WERE NOTED AT 8.7-11.3CM FROM THE TIP ELECTRODE. THE ETFE COATING WAS INTACT AT THIS LOCATION.
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
NEW INFORMATION INDICATED THE LEAD WAS EXPLANTED.
Description of Event or Problem · 1
AN ASYMPTOMATIC PATIENT PRESENTED IN CLINIC FOR NORMAL FOLLOW UP, EXTERNALIZED CONDUCTORS WERE NOTED VIA FLUOROSCOPY. NO ELECTRICAL ANOMALIES WERE DETECTED. PLANS WERE MADE FOR THE LEAD TO BE REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1581/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Required Intervention |