FDA Adverse Event
Injury
Summary report: N
RIATA ST OPTIM PASSIVE FIXATION
MDR report key: 3220192
·
Received July 11, 2013
Report
- Report Number
- 2938836-2013-04278
- Event Type
- Injury
- Date Received
- July 11, 2013
- Date of Event
- May 23, 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
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
NEW INFORMATION RECEIVED CLARIFIES THAT THE LEAD WAS CAPPED DUE TO HIGH CAPTURE THRESHOLD, LOW R-WAVES AND INTERMITTENT LOSS OF CAPTURE. NO FURTHER INFORMATION IS AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD WAS CAPPED AND REPLACED DUE TO CAPTURE ANOMALY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 321297 | RIATA ST OPTIM PASSIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7071/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Required Intervention |