FDA Adverse Event
Malfunction
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
MDR report key: 4181550
·
Received January 13, 2014
Report
- Report Number
- 2938836-2014-02743
- Event Type
- Malfunction
- Date Received
- January 13, 2014
- Date of Event
- December 4, 2012
- Manufacturer
- ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFO PROVIDED BY MFR, NO MEDWATCH FORM WAS RECEIVED. 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 HIGH VOLTAGE LEAD IMPEDANCE WAS OBSERVED OUT OF RANGE HIGH ON SVC VECTORS. NOISE WAS OBSERVED WHEN CUSTOM INTERCARDIACS WERE USED ON PREVIOUS IN CLINIC VISIT. LEAD REMAINED IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 25148 | DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D | 7120Q/52 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR |