FDA Adverse Event
Injury
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 3220269
·
Received July 11, 2013
Report
- Report Number
- 2938836-2013-04199
- Event Type
- Injury
- Date Received
- July 11, 2013
- Date of Event
- May 2, 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
INTERNAL INSULATION ABRASION WAS NOTED AT 13.5-14.6CM FROM THE DISTAL TIP. INTERNAL INSULATION ABRASION UNDER THE SVC SHOCK COIL WAS NOTED AT 25.2-26.8CM AND 26.0-26.4CM FROM THE DISTAL TIP. INTERNAL INSULATION ABRASION UNDER THE RV SHOCK COIL WAS NOTED AT 4.4-4.6CM, 4.7-4.8CM, AND 6.0-6.4CM FROM THE DISTAL TIP. THE ETFE COATING WAS INTACT AT THESE LOCATIONS. INTERNAL INSULATION ABRASION WAS NOTED UNDER THE SVC SHOCK COIL AT 24.8-25.4CM FROM THE DISTAL TIP. 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
NEW INFORMATION RECEIVED STATES THE LEAD WAS EXPLANTED AND REPLACED.
Description of Event or Problem · 1
IT WAS REPORTED THAT EXTERNALIZED CONDUCTORS WERE OBSERVED DURING FOLLOW UP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 320197 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1581/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Required Intervention |