FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION
MDR report key: 3080115
·
Received April 26, 2013
Report
- Report Number
- 2938836-2013-00958
- Event Type
- Injury
- Date Received
- April 26, 2013
- Date of Event
- February 27, 2013
- 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 EXTERNAL INSULATION ABRASION WAS FOUND AT 19.0-20.5CM FROM THE CONNECTOR PIN CONSISTENT WITH LEAD FRICTION TO THE ICD CAN. THE ETFE COATING WAS ABRADED AND THE RE CONDUCTOR WAS FRACTURED AT THIS LOCATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE SHOCKS. UPON EXPLANT, AN INSULATION ABRASION CONSISTENT WITH FRICTION TO CAN WAS OBSERVED. THE LEAD WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 180888 | DURATA STS OPTIM ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7120/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Required Intervention | (B)(4) |