FDA Adverse Event
Injury
Summary report: N
RIATA ST OPTIM ACTIVE FIXATION
MDR report key: 1223631
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03585
- Event Type
- Injury
- Date Received
- November 10, 2008
- Date of Event
- September 18, 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 SENSING COIL WAS FRACTURED CLOSE TO THE CONNECTOR RING. THE ANALYSIS OF THE FRACTURED AREA INDICATED THAT THE FRACTURE HAD OCCURRED, DUE TO FATIGUE. THIS DAMAGE IS CONSISTENT WITH DAMAGES SEEN WHEN THE CONNECTOR RING CRIMP HAS BEEN EXPOSED OUTSIDE THE CONNECTOR BORE. DUE TO THIS POSITIONING, THE SENSING COIL WAS EXPOSED TO AN INCREASED STRESS AND AN ACCELERATED FATIGUE AND OVER TIME, THE SENSING COIL FRACTURED.
Description of Event or Problem · 1
PATIENT PRESENTED TO THE HOSPITAL AFTER RECEIVING SEVERAL INAPPROPRIATE THERAPIES. EGM REVEALED NOISE WHEN PATIENT MOVED. THE DECISION WAS MADE TO EXPLANT THE LEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ST OPTIM ACTIVE FIXATION | DEFIBRILLATION LEAD | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7021/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |