FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION
MDR report key: 1895700
·
Received November 10, 2010
Report
- Report Number
- 2017865-2010-04576
- Event Type
- Injury
- Date Received
- November 10, 2010
- Date of Event
- July 29, 2010
- 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. THE REPORTED FIELD EVENTS COULD NOT BE CONFIRMED IN THE LABORATORY. ANALYSIS FOUND THE LEAD TO EXHIBIT NORMAL ELECTRICAL CHARACTERISTICS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS INTERROGATED AND THE R-WAVES HAD DECREASED AND THE PACING THRESHOLD HAD INCREASED. THE PATIENT WAS TAKEN FOR LEAD REPOSITIONING. DUE TO THE HIGH THRESHOLDS, THE LEAD WAS EXPLANTED WITH A NEW LEAD IMPLANTED, ACCEPTABLE MEASUREMENTS WERE NOTED.
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 | 7121/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Required Intervention | (B)(4) |