FDA Adverse Event
Malfunction
Summary report: N
RIATA ST OPTIM ACTIVE-FIXATION LEAD
MDR report key: 1050762
·
Received May 27, 2008
Report
- Report Number
- 2017865-2008-01714
- Event Type
- Malfunction
- Date Received
- May 27, 2008
- Date of Event
- March 14, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- MS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT FELT DISCOMFORT WHEN CAPTURE WAS OBTAINED DUE TO PERFORATION. A SHARP DROP IN IMPEDANCE WAS NOTED. THE LEAD REMAINS IMPLANTED AND THE ISSUE IS UNRESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ST OPTIM ACTIVE-FIXATION LEAD | NO BNCN FOUND FOR THIS DEVICE | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7070/60 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR |