FDA Adverse Event
Malfunction
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 2962785
·
Received February 14, 2013
Report
- Report Number
- 2938836-2013-00094
- Event Type
- Malfunction
- Date Received
- February 14, 2013
- Date of Event
- January 14, 2013
- 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
A PARTIAL LEAD WITH THE DISTAL TIP ELECTRODE PORTION MEASURING 50.6CM WAS RETURNED FOR ANALYSIS. EXTERNAL INSULATION ABRASION WAS NOTED AT 9.5-9.7CM FROM THE DISTAL TIP ELECTRODE, CONSISTENT WITH LEAD FRICTION TO ANOTHER DEVICE OR HEART FEATURE. THE ETFE COATING WAS INTACT AT THIS LOCATION. INTERNAL INSULATION ABRASION WAS NOTED AT 15.3-15.7CM FROM THE DISTAL TIP ELECTRODE. THE ETFE COATING WAS ABRADED AT THIS LOCATION.
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING FOLLOW-UP VISIT, LOW SENSING AND HIGH CAPTURE THRESHOLD WERE OBSERVED. DURING LASER EXPLANT PROCEDURE, INSULATION ABRASION WAS OBSERVED. A NEW LEAD WAS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 64945 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1580/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR |