FDA Adverse Event
Malfunction
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR
MDR report key: 3781880
·
Received April 30, 2014
Report
- Report Number
- 2938836-2014-09957
- Event Type
- Malfunction
- Date Received
- April 30, 2014
- Date of Event
- February 21, 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 Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.ANALYSIS WAS NORMAL. NO ANOMALY WAS FOUND.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, HIGH, OUT OF RANGE, HIGH VOLTAGE LEAD IMPEDANCE AND HIGH, OUT OF RANGE, PACING LEAD IMPEDANCE WERE OBSERVED. A NEW LEAD WAS IMPLANTED AND THE ISSUE PERSISTED. THE DEVICE WAS REPLACED AND THE VALUES WERE FOUND TO BE NORMAL. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 259185 | DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | 7122Q/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | (B)(4) |