FDA Adverse Event
Injury
Summary report: N
RIATA ST ACTIVE FIXATION
MDR report key: 1223476
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03636
- Event Type
- Injury
- Date Received
- November 10, 2008
- Date of Event
- September 2, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMAP95022
- Removal / Correction Number
- NA
- Adverse Event
- 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT SENSING ANOMALY AND NO CAPTURE WAS OBSERVED ON THE RIGHT VENTRICLE. LEAD WAS REPOSITIONED. PRESENCE OF FLUID IN THE PERICARDIAL SAC WAS OBSERVED DURING ECO ANALYSIS. THE PHYSICIAN PERFORMED A PERICARDIOCENTESIS. AT THE END OF THE PROCEDURE, ECO SHOWED NO PRESENCE OF FLUID THE PERICARDIAL SAC. THE PATIENT WAS REPORTED IN GOOD CONDITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ST ACTIVE FIXATION | DEFIBRILLATION LEAD | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7002/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |