FDA Adverse Event
Injury
Summary report: N
RIATA ST OPTIM ACTIVE FIXATION
MDR report key: 3101083
·
Received May 9, 2013
Report
- Report Number
- 2938836-2013-01870
- Event Type
- Injury
- Date Received
- May 9, 2013
- Date of Event
- March 11, 2013
- 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
NO MEDWATCH FORM WAS RECEIVED. EXTERNALIZED. THESE CINES WERE ALSO REVIEWED BY AN EXTERNAL TEAM OF INDEPENDENT PHYSICIANS TRAINED TO REVIEW FLUORO IMAGES FOR EXTERNALIZATION AND FOUND TO BE INCONCLUSIVE DUE TO POOR RESOLUTION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM AFTER RECEIVING SHOCKS. UPON INTERROGATION, INAPPROPRIATE HIGH VOLTAGE THERAPY WAS NOTED DUE TO LEAD NOISE. DURING EXPLANT PROCEDURE, THE LEAD WAS ATTACHED TO THE PSA AND LEAD NOISE WAS NOTED. FLUOROSCOPY WAS TAKEN AND CABLES WERE CONSIDERED TO BE EXTERNALIZED. BASED ON THE REVIEW OF MULTIPLE FREEZE-FRAME CINE VIEWS PROVIDED TO ST. JUDE MEDICAL, THE CONDUCTORS DO NOT APPEAR TO BE...
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 204236 | RIATA ST OPTIM ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7021/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Required Intervention |