FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION
MDR report key: 1954910
·
Received January 10, 2011
Report
- Report Number
- 2017865-2011-00391
- Event Type
- Injury
- Date Received
- January 10, 2011
- Date of Event
- October 18, 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 ONE OF THE FILARS OF THE SENSING COIL WAS FRACTURED AS A RESULT OF FATIGUE. THE CONNECTOR RING CRIMP SLEEVE WAS EXPOSED OUTSIDE THE CONNECTOR BORE. DUE TO THIS POSITIONING, THE SENSING COIL WAS EXPOSED TO INCREASED STRESS AND AN ACCELERATED FATIGUE. OVER TIME, THE SENSING COIL FRACTURED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD EXHIBITED A HIGH CAPTURE THRESHOLD. THE LEAD WAS EXPLANTED AND REPLACED.
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 | 7122/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |