FDA Adverse Event
Injury
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 2984374
·
Received February 28, 2013
Report
- Report Number
- 2938836-2013-00344
- Event Type
- Injury
- Date Received
- February 28, 2013
- Date of Event
- December 21, 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
- FL
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Additional Manufacturer Narrative · 1
EXTERNALIZED CONDUCTORS DUE TO INTERNAL INSULATION ABRASION WERE FOUND AT 11.0-15.6CM FROM THE DISTAL TIP ELECTRODE. THE SILICONE INSULATION WAS ABRADED AND THE RV CONDUCTOR WAS VISIBLE. INTERNAL INSULATION ABRASIONS WERE FOUND AT 14.0-15.0CM AND 19.8-20.7CM FROM DISTAL TIP ELECTRODE. EXTERNAL INSULATION ABRASION WAS FOUND AT 11.3-11.5CM FROM THE DISTAL TIP ELECTRODE CONSISTENT WITH LEAD FRICTION TO ANOTHER DEVICE. THE ETFE COATING WAS INTACT AT THESE LOCATIONS.
Description of Event or Problem · 1
IT WAS REPORTED THAT EXTERNALIZED CONDUCTORS WERE OBSERVED VIA DIAGNOSTIC IMAGING. THE PATIENT WAS ASYMPTOMATIC. ELECTRICAL FUNCTION WAS TESTED AND NO ANOMALIES WERE DETECTED. MONITORING WILL CONTINUE.
Description of Event or Problem · 1
NEW INFORMATION RECEIVED NOTES LEAD WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 87689 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1582/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Required Intervention |