FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION
MDR report key: 3220326
·
Received July 11, 2013
Report
- Report Number
- 2938836-2013-04322
- Event Type
- Injury
- Date Received
- July 11, 2013
- Date of Event
- May 7, 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. THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE. THE LEAD WAS OTHERWISE NORMAL.
Description of Event or Problem · 1
IT WAS REPORTED THAT HIGH, OUT OF RANGE HV LEAD IMPEDANCE WAS OBSERVED. DFT TESTING WAS PERFORMED AND COULD NOT BE TERMINATED BY THE ICD. EXTERNAL DEFIBRILLATION WAS USED. THE LEAD AND DEVICE WERE EXPLANTED. THE PATIENT CONDITION IS GOOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 319624 | DURATA STS OPTIM ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7121/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | (B)(4), 562434 |