FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION
MDR report key: 3781952
·
Received April 30, 2014
Report
- Report Number
- 2938836-2014-09915
- Event Type
- Injury
- Date Received
- April 30, 2014
- Date of Event
- February 17, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SE
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Additional Manufacturer Narrative · 1
EVALUATION DESCRIPTION: ANALYSIS WAS NORMAL. NO ANOMALY WAS FOUND.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT RECEIVED A PATIENT NOTIFICATION FOR HIGH, OUT OF RANGE, PACING LEAD IMPEDANCE. THE OUT OF RANGE VALUE COULD NOT BE REPRODUCED IN-CLINIC. REVIEW OF THE TRENDS SHOWED ONE OUT OF RANGE VALUE WITH ALL OTHER VALUES STABLE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT AND THE PATIENT WILL BE MONITORED.
Description of Event or Problem · 1
NEW INFORMATION RECEIVED NOTES INSULATION ABRASION ON THE RV LEAD. THE LEAD WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 258883 | DURATA STS OPTIM ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | 7120/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |