FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM
MDR report key: 1050922
·
Received May 27, 2008
Report
- Report Number
- 2017865-2008-01861
- Event Type
- Injury
- Date Received
- May 27, 2008
- Date of Event
- March 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 Location
- CA
- 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
IT WAS REPORTED THAT THE FIRST POST-OP EVALUATION, MEASUREMENTS WERE HIGH, BUT STABLE. THE PATIENT RETURNED WITH EVIDENCE FOR CARDIAC TAMPONADE. A CHEST CT SCAN AND CINE FLUORO WERE BOTH SUGGESTIVE OF PERFORATION. THE FLUID WAS DRAINED. THE PATIENT IS WELL. IT IS BELIEVED THAT THE PERICARDIAL EFFUSION/TAMPONADE WAS RELATED TO ORIGINAL LEAD. HENCE, PATIENT EXPERIENCED TWO PERFORATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DURATA STS OPTIM | NO BNCN FOUND FOR THIS DEVICE | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7120/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Hospitalization| R |