FDA Adverse Event
Injury
Summary report: N
RIATA ST OPTIM ACTIVE FIXATION
MDR report key: 1050817
·
Received May 27, 2008
Report
- Report Number
- 2017865-2008-01763
- Event Type
- Injury
- Date Received
- May 27, 2008
- Date of Event
- February 28, 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 Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
PATIENT PRESENTED TO THE ER AFTER COMPLAINING OF HEAVINESS OF THE CHEST AND HYPERTENSION. ECHOSCOPY INDICATED LEAD PERFORATION AND FLUID IN THE PERICARDIAL SPACE. A THORACOTOMY WAS PERFORMED AND FOUND THAT THE LEAD TIP HAD COMPLETELY PERFORATED THE RIGHT VENTRICULAR WALL. THE LEAD WAS EXPLANTED. THE PATIENT WAS IN STABLE CONDITION AFTER THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ST OPTIM ACTIVE FIXATION | NO BNCN FOUND FOR THIS DEVICE | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7020/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Required Intervention |