FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
MDR report key: 1955198
·
Received January 10, 2011
Report
- Report Number
- 2017865-2011-00396
- Event Type
- Injury
- Date Received
- January 10, 2011
- Date of Event
- November 19, 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
- MI
- 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
AFTER THE SYSTEM WAS IMPLANTED, INTERROGATION SHOWED AN ASYSTOLE EVENT AND PATIENT FELT PRESSURE IN THE CHEST. HIGH THRESHOLDS WERE OBSERVED. THE PATIENT WENT BACK IN THE OR AND A LEAD PERFORATION WAS FOUND. THE LEAD WAS REPOSITIONED, AND NO EFFUSION WAS NOTICED. HOWEVER, AFTER CLOSING THE POCKET, ECHO NOTED SOME EFFUSION. THE PHYSICIAN ELECTED NOT TO DRAIN THE FLUID. THE PATIENT WAS ASYMPTOMATIC WHEN CHECKED DURING THE WEEK AND TESTING SHOWED NO EFFUSION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7122Q/58 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Required Intervention |