FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION LEAD, DF4 CONNECTOR
MDR report key: 3890341
·
Received January 13, 2014
Report
- Report Number
- 2938836-2014-03650
- Event Type
- Injury
- Date Received
- January 13, 2014
- Manufacturer
- ST. JUDE MEDICAL INC., CRMD
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, 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. EVALUATION DESCRIPTION: ANALYSIS WAS NORMAL. NO ANOMALY WAS FOUND.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH INTERMITTENT UNDERSENSING. LEAD WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 30666 | DURATA STS OPTIM ACTIVE FIXATION LEAD, DF4 CONNECTOR | DEFIBRILLATION LEAD, NVY | NVY | ST. JUDE MEDICAL INC., CRMD | 7122Q/58 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |