FDA Adverse Event
Malfunction
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 2984239
·
Received February 28, 2013
Report
- Report Number
- 2938836-2013-00324
- Event Type
- Malfunction
- Date Received
- February 28, 2013
- Date of Event
- December 28, 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
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.
Additional Manufacturer Narrative · 1
EXTERNAL INSULATION ABRASION WAS NOTED AT 12.3-13.0CM, 12.3- 13.5CM AND 40.1-41.0CM FROM THE DISTAL TIP ELECTRODE, CONSISTENT WITH LEAD FRICTION TO ANOTHER DEVICE. EXTERNALIZED CONDUCTORS DUE TO INTERNAL INSULATION ABRASION WERE NOTED AT 7.3-10.8CM FROM THE DISTAL TIP ELECTRODE. INTERNAL INSULATION ABRASION WAS NOTED AT 12.5-14.1CM AND 42.5-43.6CM FROM THE DISTAL TIP ELECTRODE. THE ETFE COATING WAS INTACT AT ALL ABRASION LOCATIONS.
Description of Event or Problem · 1
IT WAS REPORTED THAT EXTERNALIZED CONDUCTORS WERE OBSERVED. LEAD WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 86652 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1581/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR |