FDA Adverse Event
Injury
Summary report: N
RIATA ST OPTIM PASSIVE FIXATION
MDR report key: 1830622
·
Received September 10, 2010
Report
- Report Number
- 2017865-2010-03360
- Event Type
- Injury
- Date Received
- September 10, 2010
- Date of Event
- July 23, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMAP950022
- 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 DURING A FOLLOW-UP VISIT DECREASED SENSING VALUES WERE NOTED. THE LEAD WAS REPOSITIONED SUCCESSFULLY.
Description of Event or Problem · 1
NEW INFORMATION NOTES THAT A DECREASE IN SENSING WAS ONCE AGAIN OBSERVED. LOSS OF CAPTURE WAS ALSO NOTED. THE PATIENT IS CURRENTLY IN THE HOSPITAL FOR AN UNRELATED PROCEDURE AND FURTHER EVALUATION IS PLANNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ST OPTIM PASSIVE FIXATION | DEFIBRILLATION LEAD | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7070/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |