FDA Adverse Event
Malfunction
Summary report: N
RIATA ST PASSIVE FIXATION
MDR report key: 7319009
·
Received March 6, 2018
Report
- Report Number
- 2938836-2018-01951
- Event Type
- Malfunction
- Date Received
- March 6, 2018
- Report Date
- March 6, 2018
- Manufacturer
- ST. JUDE MEDICAL, INC.
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- Z0458
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO X-RAY VIEWS HAVE BEEN PROVIDED TO ST. JUDE MEDICAL SO WE CANNOT FULLY CONFIRM THE EVENT. HOWEVER, BASED ON EVENT DESCRIPTION WE REGARD THIS AS A CASE OF EXTERNALIZED CABLES. NO FURTHER ANALYSIS CAN BE PERFORMED SINCE THE LEAD WILL NOT BE RETURNED TO ST. JUDE MEDICAL FOR ANALYSIS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS A DEFECT IN THE INSULATION OF THE RIGHT VENTRICULAR (RV) LEAD. NO INTERVENTION WAS PERFORMED; THE PATIENT'S CONDITION WAS STABLE AND THERE WERE NO ADVERSE CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 161723 | RIATA ST PASSIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC. | 7041/65 | 2919563 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |