FDA Adverse Event
Malfunction
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 2973369
·
Received February 21, 2013
Report
- Report Number
- 2938836-2013-00142
- Event Type
- Malfunction
- Date Received
- February 21, 2013
- Date of Event
- January 18, 2013
- 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
- PA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.
Additional Manufacturer Narrative · 1
A COMPLETE LEAD WAS RETURNED IN TWO PARTS. EXTERNAL INSULATION ABRASION CONSISTENT WITH LEAD FRICTION TO ANOTHER DEVICE WAS FOUND AT 7.8CM TO 9.2CM FROM THE DISTAL TIP. THE ETFE WAS INTACT AT THIS LOCATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT AN ASYMPTOMATIC PATIENT PRESENTED IN THE OR FOR DEVICE CHANGE OUT DUE TO NORMAL ERI. EXTERNALIZED CONDUCTORS WERE OBSERVED VIA FLUOROSCOPY. NO ELECTRICAL ANOMALIES WERE NOTED. THE LEAD WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 76112 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1580/60 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR |