FDA Adverse Event
Malfunction
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR
MDR report key: 3220227
·
Received July 11, 2013
Report
- Report Number
- 2938836-2013-04386
- Event Type
- Malfunction
- Date Received
- July 11, 2013
- Date of Event
- April 19, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- 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 ANALYSIS WAS NORMAL. NO ANOMALY WAS FOUND. ADDITIONAL TESTING COULD NOT BE PERFORMED DUE TO THE RETURNED CONDITION OF THE LEAD.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING IMPLANT PROCEDURE, DECREASED R-WAVES WERE OBSERVED MULTIPLE TIMES AND THE PACING THRESHOLD HAD INCREASED. THE PHYSICIAN DECIDED TO REPLACE THE LEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 321009 | DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7122Q/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR |