FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION
MDR report key: 1831576
·
Received September 11, 2010
Report
- Report Number
- 2017865-2010-03391
- Event Type
- Injury
- Date Received
- September 11, 2010
- Date of Event
- May 31, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- 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 RV LEAD WAS REPOSITIONED DUE TO A LOW SENSING VALUE. THE PHYSCIAN DECIDED TO CHANGE THE LEAD POSITION FROM THE INTERVENTRICULAR SEPTUM TO VENTRICLE APEX. AFTER THE LEAD WAS REPOSITIONED, ALL VALUES WERE OKAY.
Description of Event or Problem · 1
DURING THE SURGICAL PROCEDURE, IT WAS FOUND THAT THE LV AND THE RA LEAD WERE PULLED BACK ALL THE WAY INTO THE POCKET. THE RV WAS FOUND DISCONNECTED FROM THE ICD. ALL THREE LEADS WERE EXPLANTED AND REPLACED.
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 | 7120/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Required Intervention |