FDA Adverse Event
Malfunction
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 2902674
·
Received January 8, 2013
Report
- Report Number
- 2017865-2013-00340
- Event Type
- Malfunction
- Date Received
- January 8, 2013
- Date of Event
- November 20, 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
- MD
- 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
A PARTIAL LEAD WAS RETURNED CUT IN TWO SEGMENTS. INTERNAL INSULATION ABRASION WAS FOUND AT 14.3-14.6CM AND 38.1-39.0CM FROM THE HELIX. THE ETFE COATING WAS INTACT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED IN-CLINIC FOR FOLLOW-UP AND THE LEAD WAS DIAGNOSTICALLY IMAGED. EXTERNALIZED CONDUCTORS WERE NOTED. NO ELECTRICAL ANOMALIES WERE DETECTED. LEAD TO BE REVISED.
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 |
|---|---|---|---|---|---|---|---|
| 9126 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1581/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR |