FDA Adverse Event
Malfunction
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
MDR report key: 4030719
·
Received August 22, 2014
Report
- Report Number
- 2938836-2014-14707
- Event Type
- Malfunction
- Date Received
- August 22, 2014
- Date of Event
- July 6, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GB
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED NOISE. THE NOISE WAS REPRODUCIBLE WITH ARM MOVEMENT AND DEEP BREATHING. SCREENING OF THE LEAD SHOWED NO VISIBLE ANOMALIES. PROGRAMMING CHANGES WERE MADE AND NO FURTHER NOISE EPISODES WERE SEEN. THE LEAD REMAINS IMPLANTED AND THE PATIENT WILL BE MONITORED REMOTELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 510199 | DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | 7120Q/58 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |