FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION LEAD
MDR report key: 1073592
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02476
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- May 16, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
TESTING FOUND THAT THE LEAD STIFFNESS WAS WITHIN SPECIFICATION. THE LEAD EXHIBITED NORMAL ELECTRICAL CHARACTERISTICS. DRIED BODY FLUID/TISSUE INSIDE THE HEADER AND IN THE DISTAL INSULATION PREVENTED HELIX EXTENSION AND DIFFICULTY WITH STYLET INSERTION. HELIX FUNCTION WAS NORMAL AFTER CLEANING.
Description of Event or Problem · 1
THE LEAD WAS EXPLANTED DUE TO A LEAD PERFORATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DURATA STS OPTIM ACTIVE FIXATION LEAD | DEFIBRILLATION LEAD | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7120/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |