FDA Adverse Event
Malfunction
Summary report: N
DURATA STS OPTIM PASSIVE FIXATION, DF4 CONNECTOR
MDR report key: 4172456
·
Received January 13, 2014
Report
- Report Number
- 2938836-2014-01784
- Event Type
- Malfunction
- Date Received
- January 13, 2014
- Date of Event
- October 31, 2011
- Manufacturer
- ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFO PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD. EVAL: ANALYSIS WAS NORMAL. NO ANOMALY WAS FOUND.
Description of Event or Problem · 1
IT WAS REPORTED DURING IMPLANT, THE LEAD WAS PRODUCING HIGH IMPEDANCE AND LOSS OF CAPTURE. THE LEAD WAS NOT USED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 29147 | DURATA STS OPTIM PASSIVE FIXATION, DF4 CONNECTOR | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D | 7170Q/58 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR |