FDA Adverse Event
Injury
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 3090241
·
Received May 2, 2013
Report
- Report Number
- 2938836-2013-01056
- Event Type
- Injury
- Date Received
- May 2, 2013
- Date of Event
- March 6, 2013
- 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
- OH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Additional Manufacturer Narrative · 1
EVALUATION DESCRIPTION: A PARTIAL LEAD WITH THE IS-1 CONNECTOR BOOT PORTION MEASURING 6.1 CM WAS RETURNED FOR ANALYSIS. THE DAMAGE WAS FOUND SUSTAINED DURING SURGICAL PROCEDURE. THE PORTION OF THE LEAD WAS OTHERWISE NORMAL. WITHOUT RETURN OF THE ENTIRE LEAD A COMPLETE ANALYSIS COULD NOT BE CONFIRMED. (B)(4).
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT EXTERNALIZED CONDUCTORS WERE OBSERVED ON THE LEAD. NO ELECTRICAL ANOMALIES WERE NOTED AND THE PATIENT WAS ASYMPTOMATIC.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 191526 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1580/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Required Intervention |