FDA Adverse Event
Injury
Summary report: N
RIATA ST ACTIVE FIXATION LEAD
MDR report key: 1073073
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02319
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- April 15, 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.
Description of Event or Problem · 1
PATIENT PRESENTED AT FOLLOW-UP WITH NO CAPTURE AND LOW SENSING SIGNALS ON THE LEAD. ECHO REVEALED PERFORATION THROUGH THE RV APEX INTO THE PERICARDIUM. NO PERICARDIAL EFFUSION WAS NOTED. THE LEAD WAS EXPLANTED AND SUCCESSFULLY REPLACED WITH NO CONSEQUENCES TO THE PATIENT. LEAD WILL NOT BE RETURNED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ST ACTIVE FIXATION LEAD | DEFIBRILLATION LEAD | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7001/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |