FDA Adverse Event
Malfunction
Summary report: N
RIATA ST PASSIVE FIXATION
MDR report key: 2984270
·
Received February 28, 2013
Report
- Report Number
- 2938836-2013-00403
- Event Type
- Malfunction
- Date Received
- February 28, 2013
- Date of Event
- December 27, 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
- AZ
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.
Additional Manufacturer Narrative · 1
THE REPORTED INSULATION ABRASION OBSERVED FROM THE FIELD WAS CONFIRMED. INTERNAL INSULATION ABRASIONS WERE FOUND AT 10.0 TO 11.5CM AND 11.0 TO 12.0CM FROM THE DISTAL TIP. THE RE AND RV CONDUCTORS ETFE COATING WAS INTACT AT BOTH LOCATIONS.
Description of Event or Problem · 1
IT WAS REPORTED THAT EXTERNALIZED CONDUCTORS WERE OBSERVED VIA FLUOROSCOPY. THE LEAD WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 87667 | RIATA ST PASSIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7040/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR |