FDA Adverse Event
Malfunction
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 2984535
·
Received February 28, 2013
Report
- Report Number
- 2938836-2013-00313
- Event Type
- Malfunction
- Date Received
- February 28, 2013
- Date of Event
- January 15, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- Z0457
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Additional Manufacturer Narrative · 1
A PARTIAL LEAD WITH THE DISTAL TIP ELECTRODE MEASURING 51.3CM WAS RETURNED FOR ANALYSIS. EXTERNAL INSULATION ABRASION WAS NOTED AT 17.7-18.3CM FROM THE DISTAL TIP ELECTRODE CONSISTENT WITH LEAD FRICTION TO ANOTHER DEVICE OR FEATURE OF THE HEART. EXTERNALIZED CONDUCTORS DUE TO INTERNAL INSULATION ABRASION WERE NOTED AT 13.4-17.3CM FROM THE DISTAL TIP ELECTRODE. THE ETFE COATING WAS INTACT AT THESE LOCATIONS.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING DEVICE UPGRADE, EXTERNALIZED CONDUCTORS WERE OBSERVED VIA FLUOROSCOPY. THE LEAD WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 88403 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1581/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | (B)(4) |