FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
MDR report key: 2242509
·
Received September 10, 2011
Report
- Report Number
- 2017865-2011-06481
- Event Type
- Injury
- Date Received
- September 10, 2011
- Date of Event
- June 29, 2011
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- 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
PATIENT RETURNED TO THE HOSPITAL ABOUT 3 MONTHS POST LEAD REPOSITIONING. INAPPROPRIATE SHOCKS WERE OBSERVED. THE PHYSICIAN SUSPECTED THE LEAD WAS DISLODGED. THERE WAS NO CAPTURE AND SENSING WAS LOW. HIGH VOLTAGE THERAPY WAS PROGRAMMED OFF. PATIENT WAS INFORMED ABOUT THE RISK.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING FOLLOW-UP, A DECREASE IN SENSING AND AN INCREASE IN CAPTURE WERE OBSERVED. FLUOROSCOPIC VIEW SHOWED DISLODGEMENT. THE LEAD WAS REPOSITIONED.
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 | Required Intervention |