FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION
MDR report key: 4221027
·
Received November 3, 2014
Report
- Report Number
- 2938836-2014-17471
- Event Type
- Injury
- Date Received
- November 3, 2014
- Date of Event
- September 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
- VA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. EVALUATION DESCRIPTION INCLUDED. A PARTIAL LEAD WITH THE CONNECTOR PIN MEASURING 11.2CM WAS RETURNED FOR ANALYSIS. THE PORTION OF THE LEAD THAT WAS RETURNED WAS OTHERWISE NORMAL. WITHOUT RETURN OF THE ENTIRE LEAD, A COMPLETE ANALYSIS COULD NOT BE PERFORMED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC AFTER RECEIVING A VIBRATORY ALERT. HIGH, OUT OF RANGE, PACING LEAD IMPEDANCE AND HIGH CAPTURE THRESHOLD WERE OBSERVED. CLAVICULAR CRUSH WAS NOTED. THE LEAD WAS CAPPED AND REPLACED. PATIENT WAS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 703070 | DURATA STS OPTIM ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | 7121/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Required Intervention |