FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION
MDR report key: 1223164
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03728
- Event Type
- Injury
- Date Received
- November 10, 2008
- Date of Event
- September 26, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMAP95022
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED THE DAMAGE FOUND IS CONSISTENT WITH THAT OCCURING AT THE TIME OF THE SURGICAL PROCEDURE. THE LEAD TIP STIFFNESS TEST WAS PERFORMED AND THE LEAD WAS WITHIN SPECIFICATION. REVIEW OF QUALITY RECORDS.
Description of Event or Problem · 1
IT WAS REPORTED THAT HIGH PACING THRESHOLDS, LOW IMPEDANCE AND LOW R-WAVES WERE OBSERVED. RV LEAD PERFORATION WAS ALSO SUSPECTED. PATIENT HAD CARDIAC TAMPONADE 2 DAYS POST IMPLANT OF SHILEY CATHETER. PATIENT HAD HISTORY OF SEPSIS POST IMPLANT WHICH COULD NOT BE DETERMINED. THE SYSTEM WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DURATA STS OPTIM ACTIVE FIXATION | DEFIBRILLATION LEAD | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7121/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |