FDA Adverse Event
Malfunction
Summary report: N
RIATA PASSIVE FIXATION
MDR report key: 1895563
·
Received November 10, 2010
Report
- Report Number
- 2017865-2010-04272
- Event Type
- Malfunction
- Date Received
- November 10, 2010
- Date of Event
- September 9, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. (B)(6) LABORATORY TECHNICIAN. JUDE MEDICAL (B)(4) LABORATORY; FAILURE (EVENT) OBSERVED DURING ANALYSIS. ANALYSIS FOUND INSULATION ABRASION AT 12.3CM FROM THE CONNECTOR PIN. THIS ABRASION IS CONSISTENT WITH THAT OF FRICTION TO THE CAN. FURTHER EXAMINATION SHOWED AN INSIDE- OUT ABRASION AT 9.5CM FROM THE DISTAL TIP.
Description of Event or Problem · 1
THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.
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 |