FDA Adverse Event
Injury
Summary report: N
RIATA ST ACTIVE FIXATION
MDR report key: 2242744
·
Received September 10, 2011
Report
- Report Number
- 2017865-2011-06235
- Event Type
- Injury
- Date Received
- September 10, 2011
- Date of Event
- June 30, 2011
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED EXTERNAL ABRASION DUE TO FRICTION TO THE ICD CAN WAS FOUND. ABRASION IN THIS AREA ALLOWED FOR THE RING ELECTRODES TO COME INTO CONTACT WITH THE ICD CAN, RESULTING IN THE NOISE REPORTED IN THE FIELD. LEAD IMPEDANCES WERE FOUND TO BE NORMAL.
Description of Event or Problem · 1
IT WAS REPORTED THAT AN ALERT WAS RECEIVED FOR POSSIBLE OUTPUT CIRCUIT DAMAGE AND LOW LEAD IMPEDANCE. NOISE WAS OBSERVED WITH PROVOCATION TESTS AND SEVERAL NOISE EPISODES CLASSIFIED AS VF WERE STORED. THE LEAD WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ST ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7000/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | (B)(4) |