FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM PASSIVE FIXATION
MDR report key: 1954813
·
Received January 10, 2011
Report
- Report Number
- 2017865-2011-00422
- Event Type
- Injury
- Date Received
- January 10, 2011
- Date of Event
- October 12, 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD EXHIBITED A CONSTANT INCREASE IN CAPTURE THRESHOLDS AND A DECREASE IN SENSING THRESHOLDS. FLUOROSCOPY SHOWED A VERY SUBTLE LEAD DISLOCATION. WHEN THE POCKET WAS OPENED, THE LEAD WAS FOUND TO BE STABLE IN ITS POSITION. A NEW SENSE/PACE LEAD WAS ADDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DURATA STS OPTIM PASSIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7170/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |