FDA Adverse Event
Malfunction
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 2902693
·
Received January 8, 2013
Report
- Report Number
- 2017865-2013-00356
- Event Type
- Malfunction
- Date Received
- January 8, 2013
- Date of Event
- November 15, 2012
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- Z0457
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Additional Manufacturer Narrative · 1
EXTERNAL CONDUCTORS DUE TO INTERNAL INSULATION ABRASION WERE FOUND AT 8.7-13.5CM FROM THE DISTAL TIP ELECTRODE. EXTERNAL INSULATION ABRASION WAS FOUND AT 6.8-7.1CM FROM THE DISTAL TIP ELECTRODE, CONSISTENT WITH LEAD FRICTION TO ANOTHER DEVICE. THE ETFE COATING WAS INTACT AT THESE LOCATIONS.
Additional Manufacturer Narrative · 1
DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.
Description of Event or Problem · 1
AN ASYMPTOMATIC PATIENT PRESENTED IN CLINIC FOR FOLLOW UP AND EXTERNALIZED CONDUCTORS WERE NOTED VIA IMAGING. NO ELECTRICAL ANOMALIES WERE NOTED. LEAD WILL BE MONITORED.
Description of Event or Problem · 1
NEW INFORMATION RECEIVED STATED THAT THE LEAD WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 8828 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1590/60 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR |