FDA Adverse Event
Malfunction
Summary report: N
RIATA ST ACTIVE FIXATION
MDR report key: 2973359
·
Received February 21, 2013
Report
- Report Number
- 2938836-2013-00183
- Event Type
- Malfunction
- Date Received
- February 21, 2013
- Date of Event
- December 6, 2012
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- Z0458
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX
- 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
EXTERNAL INSULATION ABRASION WAS FOUND AT 46.0-46.5CM FROM THE TIP ELECTRODE, CONSISTENT WITH LEAD FRICTION TO THE ICD CAN. THE ETFE COATING WAS INTACT AT THE SAME LOCATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT EXTERNALIZED CONDUCTORS WERE OBSERVED BETWEEN THE RV AND SVC COIL. NO ELECTRICAL ANOMALIES WERE NOTED. LEAD WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 76460 | RIATA ST ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7000/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR |