FDA Adverse Event
Malfunction
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 1896005
·
Received November 10, 2010
Report
- Report Number
- 2017865-2010-04303
- Event Type
- Malfunction
- Date Received
- November 10, 2010
- Date of Event
- September 25, 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 THE PATIENT RECEIVED INAPPROPRIATE SHOCKS. NOISE WAS OBSERVED ON THE VENTRICULAR CHANNEL. HIGH THRESHOLD, HIGH SENSE/PACE IMPEDANCE AND LOW R-WAVE AMPLITUDE WERE OBSERVED. THE LEAD WAS LEFT IN PLACE WITH THE HIGH VOLTAGE THERAPIES DISABLED AS THE PATIENT HAS NEVER RECEIVED THERAPY FROM THE DEVICE NOR HAS INDICATION FOR VENTRICULAR PACING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1580/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR |