FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION
MDR report key: 1955134
·
Received January 10, 2011
Report
- Report Number
- 2017865-2011-00225
- Event Type
- Injury
- Date Received
- January 10, 2011
- Date of Event
- October 22, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. OTHER TEXT : NA.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD PERFORATED THE CARDIAC WALL DURING THE IMPLANT. DURING THE CASE, LEAD IMPEDANCES ROSE AND CAPTURE WAS LOST. CARDIAC TAMPONADE RESULTED FROM THE PERFORATION AND WAS RESOLVED VIA PERICARDIOCENTESIS. THE LEAD WAS REPOSITIONED ON THE SEPTAL WALL AND MEASUREMENTS WERE STABLE AND IN-RANGE. THE PATIENT IS RECOVERING FROM THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DURATA STS OPTIM ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7120/60 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |