FDA Adverse Event
Injury
Summary report: N
RIATA ST OPTIM ACTIVE-FIXATION LEAD
MDR report key: 1073543
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02437
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- May 18, 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
NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD HAD MIGRATED TO THE LEFT LUNG AND CLOTTED THE CAVITY. THE PATIENT HAD BEEN TRANSFERRED FROM ANOTHER HOSPITAL WHERE HE HAD A CHEST TUBE INSERTED FOR HEMOTHORAX. THE LEAD WAS REPOSITIONED TO THE SEPTAL AREA AND PHYSICIAN REPAIRED THE CAVITY IN THE LEFT VENTRICLE. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ST OPTIM ACTIVE-FIXATION LEAD | DEFIBRILLATION LEAD | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7022/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |