FDA Adverse Event
Malfunction
Summary report: N
RIATA ST PASSIVE FIXATION
MDR report key: 1895954
·
Received November 10, 2010
Report
- Report Number
- 2017865-2010-04454
- Event Type
- Malfunction
- Date Received
- November 10, 2010
- Date of Event
- September 24, 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT REVIEW OF THE STORED EGMS SHOWED THE PATIENT RECEIVED INAPPROPRIATE HV THERAPY. NOISE WAS NOTED ON THE LEAD. LEAD INSULATION DAMAGE SUSPECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ST PASSIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7040/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |