FDA Adverse Event
Injury
Summary report: N
RIATA ST ACTIVE FIXATION
MDR report key: 1223564
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03603
- Event Type
- Injury
- Date Received
- November 10, 2008
- Date of Event
- September 15, 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
THE FIELD EXPERIENCE WAS CONFIRMED. THE REPORTED NOISE WAS CAUSED BY AN ABRADED OUTER INSULATION AND INNER COIL. THE LEAD ABRASIONS ARE CONSISTENT WITH THAT PRODUCED BY FRICTION WITH THE ICD CAN.
Description of Event or Problem · 1
NOISE WAS OBSERVED. LEAD FRACTURE WAS SUSPECTED. LEAD WAS EXPLANTED.
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 |