FDA Adverse Event
Malfunction
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 2973352
·
Received February 21, 2013
Report
- Report Number
- 2938836-2013-00156
- Event Type
- Malfunction
- Date Received
- February 21, 2013
- Date of Event
- January 7, 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
EXTERNALIZED CONDUCTORS DUE TO INTERNAL INSULATION ABRASION WERE FOUND AT 8.2-11.5CM AND 10.3-13.2CM FROM THE HELIX. INTERNAL INSULATION ABRASIONS WERE FOUND UNDER THE RV SHOCK COIL AT 3.1-3.3CM, 3.5-3.9CM, 4.4-5.3CM, AND 6.1 -6.6CM FROM THE HELIX. THE ETFE COATING WAS INTACT AT THESE LOCATIONS. INTERNAL INSULATION ABRASIONS WERE FOUND UNDER THE SVC SHOCK COIL AT 17.3-17.8CM, 21.4-22.0CM, AND 23.1-23.3CM FROM THE HELIX. AT 21.4-22.0CM FROM THE HELIX, THE ETFE COATING ON ONE RV CONDUCTOR WAS ABRADED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE SHOCKS DUE TO NOISE. EXTERNALIZED CONDUCTORS WERE NOTED. THE LEAD WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 77109 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1580/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR |