FDA Adverse Event
Malfunction
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR
MDR report key: 4089562
·
Received January 13, 2014
Report
- Report Number
- 2938836-2014-05788
- Event Type
- Malfunction
- Date Received
- January 13, 2014
- Date of Event
- April 9, 2012
- Manufacturer
- ST. JUDE MEDICA, INC. CRMD
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION 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. ANALYSIS WAS NORMAL. NO ANOMALIES WERE FOUND.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING IMPLANT THE LEAD WAS PLACED IN THE RIGHT VENTRICULAR APEX AND HELIX EXTENDED TO FIND LOW R WAVES. PHYSICIAN OPTED TO MOVE THE LEAD BUT HAD DIFFICULTY RETRACTING TH HELIX. THIS LEAD WAS NOT IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 22554 | DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR | DEFIBRILLATION LEAD, NVY | NVY | ST. JUDE MEDICA, INC. CRMD | 7120Q/58 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR |