FDA Adverse Event
Injury
Summary report: N
RIATA PASSIVE FIXATION
MDR report key: 2242783
·
Received September 10, 2011
Report
- Report Number
- 2017865-2011-06041
- Event Type
- Injury
- Date Received
- September 10, 2011
- 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 Location
- MA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED THE LEAD WAS RETURNED CUT IN TWO PIECES. VISUAL EVALUATION NOTED EXTERNAL INSULATION ABRASION DUE TO FRICTION WITH THE ICD CAN. MULTIPLE EXTERNALIZED INSULATION ABRASIONS WERE FOUND; THE RV CABLE ETFE COATINGS OF SEVERAL ABRASION ZONES WERE ABRADED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD CONDUCTOR CABLES WERE EXTERNALIZED DUE TO INSULATION DAMAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA PASSIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1571/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |