FDA Adverse Event
Malfunction
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
MDR report key: 3890598
·
Received January 13, 2014
Report
- Report Number
- 2938836-2014-04416
- Event Type
- Malfunction
- Date Received
- January 13, 2014
- Date of Event
- September 16, 2012
- Manufacturer
- ST. JUDE MEDICAL, INC. CRMD
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
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.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC FOR A ROUTINE FOLLOW UP. THE LEAD EXHIBITED NOISE DUE TO ELECTROMAGNETIC INTERFERENCE. ANOTHER EPISODE OF NOISE WAS POSSIBLY DUE TO LEAD FRACTURE. THE PATIENT WAS TO BE MONITORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 27861 | DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR | DIFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC. CRMD | 7121Q/58 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR |