FDA Adverse Event
Injury
Summary report: N
RIATA ST PASSIVE FIXATION LEAD
MDR report key: 1073590
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02474
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- April 17, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMA00001
- 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 ANALYSIS FOUND THAT ONLY THE PROXIMAL END OF THE LEAD WAS RETURNED IN THREE PIECES. NORMAL ELECTRICAL CHARACTERISTICS WERE NOTED. NO ANOMALIES WERE FOUND THAT COULD EXPLAIN THE EVENT DESCRIBED IN THE FIELD. SINCE THE DISTAL END OF THE LEAD WAS NOT RETURNED, FURTHER ANALYSIS COULD NOT BE PERFORMED AND THE COMPLAINT COULD NOT BE VERIFIED.
Description of Event or Problem · 1
LEAD REVISION WAS PERFORMED DUE TO A SENSING AND PACING ANOMALY. THE SVC COIL WAS ABRADED AT THE SUBCLAVIAN RIB. INAPPROPRIATE THERAPY WAS OBSERVED. THE PHYSICIAN WAS HAVING DIFFICULTIES EXPLANTING THE LEAD. HENCE, ONLY A PORTION OF THE LEAD WAS REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ST PASSIVE FIXATION LEAD | DEFIBRILLATION LEAD | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7040/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |