FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION
MDR report key: 1955166
·
Received January 10, 2011
Report
- Report Number
- 2017865-2011-00253
- Event Type
- Injury
- Date Received
- January 10, 2011
- Date of Event
- October 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 ANALYSIS FOUND THAT THE PACING COIL WAS FRACTURED AT 28 CM FROM THE CONNECTOR PIN. THE SILICONE AND PTFE INSULATIONS WERE ABRADED. X-RAY REVEALED THAT THE FRACTURE WAS A RESULT OF FATIGUE. DUE TO INCREASED STRESS AND AN ACCELERATED FATIGUE, OVER TIME THE PACING COIL FRACTURED. THE LOCATION AND MODE OF THE FRACTURE ARE CONSISTENT WITH THAT PRODUCED BY CLAVICULAR CRUSH.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A FOLLOW-UP, HIGH IMPEDANCE AND AN INCREASE IN THRESHOLD WERE OBSERVED. AS SUCH, THE LEAD WAS EXPLANTED.
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 | 7120/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |