FDA Adverse Event
Injury
Summary report: N
RIATA ST OPTIM ACTIVE FIXATION
MDR report key: 3220190
·
Received July 11, 2013
Report
- Report Number
- 2938836-2013-04265
- Event Type
- Injury
- Date Received
- July 11, 2013
- Date of Event
- February 25, 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 Location
- AZ
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
NEW INFORMATION RECEIVED NOTES THAT THE LEAD WAS CAPPED AND REPLACED DUE TO LEAD FRACTURE.
Description of Event or Problem · 1
NEW INFORMATION RECEIVED INDICATED THAT AN X-RAY WAS TAKEN PRIOR TO THE LEAD BEING CAPPED, SHOWING EXTERNALIZED CONDUCTORS NEAR THE DEVICE HEADER. BASED ON THE REVIEW OF THE FLUOROSCOPY IMAGES PROVIDED TO ST. JUDE MEDICAL, THE CONDUCTORS ARE NOT CONSIDERED TO BE EXTERNALIZED. AN INDEPENDENT PHYSICIAN TRAINED TO ADJUDICATE EXTERNALIZATION ALSO REVIEWED THE FLUOROSCOPY IMAGES AND CONCURRED THERE WERE NO EXTERNALIZED CONDUCTORS.
Description of Event or Problem · 1
IT WAS REPORTED THAT AN ALERT WAS RECEIVED FOR LEAD NOISE. OCCASIONAL OVERSENSING WAS OBSERVED. REPROGRAMMING WAS DONE AND LEAD REMAINS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 320272 | RIATA ST OPTIM ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7020/60 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Required Intervention |