FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM ACTIVE-FIXATION LEAD
MDR report key: 1073173
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02530
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- April 22, 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 Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED THE ANALYSIS OF THE LEAD DID NOT REVEAL ANY DEVICE CONDITION THAT WOULD HAVE CONTRIBUTED TO THE DISLODGEMENT. THE ELECTRICAL CHARACTERISTICS OF THE LEAD WERE FOUND TO BE NORMAL. ALL MEASURED DATA WERE WITHIN PRODUCT SPECIFICATIONS. MECHANICAL AND VISUAL ANALYSIS FOUND THE HELIX CLOGGED WITH BODY FLUID/TISSUE, PREVENTING IT FROM ACTUATION. THE ENSUING RESISTANCE MAY HAVE RESULTED IN AN OVER-TORQUE CONDITION. AFTER DESTRUCTIVE ANALYSIS AND CLEANING, THE HELIX WAS FOUND TO FUNCTION NORMALLY.
Description of Event or Problem · 1
THE LEAD WAS EXPLANTED DUE TO DISLODGEMENT.
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 | 7120/60 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |